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125742 0_20219001.P0.pdfNovember 1, 2023912 KB
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125742_S116_M1_lab 1448 1 0.pdfNovember 1, 20231 MB
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125742_S112_S2_M3_32s2_control critical steps manuf process.pdfNovember 1, 20232 MB
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125742_S111_M1_letter of authorization.pdfNovember 1, 2023739 KB
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125742_S111_M1_356h.pdfNovember 1, 20234 MB
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125742_S80_M1_cover.pdfNovember 1, 2023734 KB
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125742_S63_M1_response 18aug2021.pdfNovember 1, 20232 MB
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125742_S61_M1_response 17aug2021.pdfNovember 1, 20232 MB
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125742_S61_M1_cover.pdfNovember 1, 2023668 KB
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125742_S60_M3_32s2_control critical steps manuf process.pdfNovember 1, 20232 MB
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125742_S60_M1_response 17aug2021.pdfNovember 1, 20232 MB
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125742_S60_M1_cover.pdfNovember 1, 20232 MB
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125742_S59_M1_response 17aug2021.pdfNovember 1, 20231 MB
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125742_S59_M1_cover.pdfNovember 1, 2023672 KB
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125742_S57_M3_32p3_manufacturer diluent.pdfNovember 1, 20232 MB
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125742_S57_M1_response 16aug2021.pdfNovember 1, 20232 MB
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STN 124742_Courtesy Copy_Pfizer BioNTech Comirnaty STN 125742 COVID 19 Vaccine Lot Notifications (2021).pdfNovember 1, 2023200 KB
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FDA CBER 2021 5683 1150835 1200874_Slipsheet.pdfNovember 1, 202369 KB
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125742 0_20219009.P0.pdfNovember 1, 2023889 KB
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125742 0_20219001.PC1.pdfNovember 1, 2023912 KB
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125742_S56_M1_response 13aug2021.pdfNovember 1, 20232 MB
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125742_S56_M1_cover.pdfNovember 1, 2023672 KB
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125742_S55_M3_32p8_stability summary.pdfNovember 1, 20233 MB
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125742_S55_M3_32p8_stability data long term.pdfNovember 1, 20233 MB
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125742_S55_M2_introduction.pdfNovember 1, 202311 MB
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125742_S55_M2_drug product stability.pdfNovember 1, 20233 MB
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125742_S55_M2_32p8_stability data accelerated.pdfNovember 1, 20233 MB
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125742_S55_M1_cover.pdfNovember 1, 2023767 KB
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125742_S53_M1_response 13aug2021.pdfNovember 1, 20231 MB
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125742_S53_M1_cover.pdfNovember 1, 2023675 KB
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125742_S50_M3_32r_comirnaty lot release template.pdfNovember 1, 20232 MB
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125742_S50_M1_response 13aug2021.pdfNovember 1, 20232 MB
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125742_S48_M1_response 06aug2021.pdfNovember 1, 20232 MB
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125742_S47_M3_32p3_manufacturer diluent.pdfNovember 1, 20232 MB
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125742_S47_M1_response 11aug2021.pdfNovember 1, 20232 MB
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125742_S44_M1_response 10aug2021.pdfNovember 1, 20232 MB
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125742_S43_M3_32p3_manufacturers.pdfNovember 1, 20232 MB
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125742_S43_M1_response 05aug2021.pdfNovember 1, 20232 MB
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125742_S42_M3_32r_comirnaty lot release template.pdfNovember 1, 2023709 KB
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125742_S42_M1_response 04aug2021.pdfNovember 1, 20234 MB
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125742_S40_M1_response 06aug2021.pdfNovember 1, 20232 MB
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125742_S37_M1_response 05aug2021.pdfNovember 1, 20232 MB
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125742_S36_M1_response 02aug2021.pdfNovember 1, 20232 MB
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125742_S34_M3_32a3_excipient information nomenclature alc 0315.pdfNovember 1, 20232 MB
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125742_S57_M1_cover.pdfNovember 1, 20232 MB
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125742_S30_M1_cover.pdfNovember 1, 2023671 KB
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125742_S26_M1_fda bnt cl.pdfNovember 1, 2023996 KB
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125742_S26_M1_andover 483 response.pdfNovember 1, 20231 MB
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125742_S22_M1_response 16jul2021.pdfNovember 1, 20231 MB
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125742_S19_M1_response 02jul2021.pdfNovember 1, 20232 MB
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125742_S17_M1_reponse 09jul2021.pdfNovember 1, 20232 MB
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125742_S17_M1_cover.pdfNovember 1, 2023674 KB
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125742_S15_M3_32r_comirnaty lot release 16jul2021.pdfNovember 1, 20231 MB
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125742_S15_M1_response 16jul2021 lrp samples.pdfNovember 1, 20231 MB
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125742_S15_M1_cover.pdfNovember 1, 2023675 KB
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125742_S11_M3_32r_pf 07302048 dp rm coa.pdfNovember 1, 2023634 KB
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125742_S11_M3_32r_fc3181 coa.pdfNovember 1, 2023840 KB
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125742_S11_M3_32r_677365 1g a 010 coa.pdfNovember 1, 2023636 KB
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125742_S11_M3_32r_677315o 1g a 010 coa.pdfNovember 1, 2023635 KB
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125742_S11_M3_32r_21y513c2301 coa.pdfNovember 1, 20231 MB
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125742_S11_M1_response 25jun2021 cmc.pdfNovember 1, 20232 MB
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125742_S11_M1_cover.pdfNovember 1, 20232 MB
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125742_S5_M1_response 20 may 2021 facilities.pdfNovember 1, 20231 MB
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125742_S5_M1_cover.pdfNovember 1, 2023725 KB
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125742_S2_M3_32s4_validation analyt procedure overview.pdfNovember 1, 20232 MB
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125742_S2_M3_32s4_specification.pdfNovember 1, 20232 MB
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125742_S2_M3_32s4_analytical procedure overview.pdfNovember 1, 20232 MB
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125742_S34_M1_cover.pdfNovember 1, 2023668 KB
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125742_S30_M1_response 26jul2021.pdfNovember 1, 20231 MB
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125742_S2_M3_32r_reg info manufacturing schedules.pdfNovember 1, 20232 MB
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125742_S2_M3_32r_reg info lot release documentation package.pdfNovember 1, 20234 MB
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125742_S2_M3_32p53_validation analytical procedures overview.pdfNovember 1, 20232 MB
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125742_S2_M3_32p53_validation analytical procedure rt pcr.pdfNovember 1, 20232 MB
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125742_S2_M3_32p53_validation analytical procedure cap gel electro.pdfNovember 1, 20232 MB
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125742_S2_M3_32p52_analytical procedure subvis particulate matter.pdfNovember 1, 20232 MB
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125742_S2_M3_32p52_analytical procedure rt pcr.pdfNovember 1, 20232 MB
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125742_S2_M3_32p52_analytical procedure overview.pdfNovember 1, 20232 MB
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125742_S2_M3_32p52_analytical procedure osmometry.pdfNovember 1, 20232 MB
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125742_S2_M3_32p52_analytical procedure endotoxin.pdfNovember 1, 20232 MB
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125742_S2_M3_32p52_analytical procedure cap gel electro.pdfNovember 1, 20232 MB
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125742_S2_M3_32p8_stability summary.pdfNovember 1, 20232 MB
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125742_S2_M3_32p8_stability data thermal stress cycling.pdfNovember 1, 20233 MB
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125742_S2_M3_32p8_stability data photostability.pdfNovember 1, 20232 MB
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125742_S2_M3_32p8_stability data long term.pdfNovember 1, 20232 MB
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125742_S2_M3_32p8_stability data accelerated.pdfNovember 1, 20232 MB
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125742_S2_M3_32p8_postapproval stability.pdfNovember 1, 20232 MB
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125742_S2_M3_32p5_specifications.pdfNovember 1, 20232 MB
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125742_S2_M3_32p5_batch analyses.pdfNovember 1, 20233 MB
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125742_S2_M3_32p4_novel excipients.pdfNovember 1, 20232 MB
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125742_S2_M3_32p4_excipients human animal.pdfNovember 1, 20232 MB
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125742_S2_M3_32p3_control critical steps in process mon control overview.pdfNovember 1, 20232 MB
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125742_S2_M3_32p3_batch formula.pdfNovember 1, 20232 MB
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125742_S2_M3_32p2_pharmaceutical development introduction.pdfNovember 1, 20232 MB
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125742_S2_M3_32p1_description and composition.pdfNovember 1, 20232 MB
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125742_S2_M3_32a3_excipient information structure alc 0315.pdfNovember 1, 20232 MB
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125742_S2_M3_32a3_excipient information structure alc 0159.pdfNovember 1, 20232 MB
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125742_S2_M3_32a3_excipient information nomenclature alc 0315.pdfNovember 1, 20232 MB
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125742_S2_M3_32a3_excipient information nomenclature alc 0159.pdfNovember 1, 20232 MB
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125742_S2_M3_32a3_excipient information excipients alc 0315.pdfNovember 1, 20232 MB
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125742_S2_M3_32a3_excipient information excipients alc 0159.pdfNovember 1, 20232 MB
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125742_S2_M3_32a2_adventitious agents puurs.pdfNovember 1, 20232 MB
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125742_S2_M3_32a2_adventitious agents kalamazoo.pdfNovember 1, 20232 MB
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125742_S2_M3_32a2_adventitious agents andover.pdfNovember 1, 20232 MB
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125742_S2_M2_introduction.pdfNovember 1, 20232 MB
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125742_S2_M2_drug product stability.pdfNovember 1, 20232 MB
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125742_S2_M2_drug product reference stand or materials.pdfNovember 1, 20232 MB
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125742_S2_M2_drug product description composition drug prod.pdfNovember 1, 20232 MB
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125742_S2_M2_appendices adv agen safe val.pdfNovember 1, 20232 MB
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125742_S1_M1_financial cert summary.pdfNovember 1, 2023715 KB
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125742_S1_M1_financial cert 3455.pdfNovember 1, 20232 MB
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125742_S1_M1_1.9.4_ipsp agreed.pdfNovember 1, 20232 MB
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125742_S1_M1_1.9.2_ped studies deferral req.pdfNovember 1, 202311 MB
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138_BLA_125742_STN125742 release test (pH) lots FD7220, FE3592, FF2587.pdfNovember 1, 20231 MB
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137_BLA_125742_Endotoxin release tests lots FD7220, FE3592, FF2587.pdfNovember 1, 2023813 KB
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125742_S2_M3_32s2_manufacturer.pdfNovember 1, 20232 MB
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125742_S2_M3_32s2_control critical steps manuf process.pdfNovember 1, 20232 MB
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133_Courtesy Copy_BLA 125742 0_Benefit Risk Assessment Review Memo COMIRNATY.pdfNovember 1, 20233 MB
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132_BLA 125742 0_09 13 2021_Memo_Committee Memo_Review (1).pdfNovember 1, 20231 MB
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131_Courtesy Copy_BLA 125742 0_Clinical Review Memo, August 23, 2021 COMIRNATY.pdfNovember 1, 20231 MB
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129_BLA 125742 0_08 30 2021_Telecon_Other.pdfNovember 1, 2023638 KB
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128_BLA 125742 0_08 30 2021_Telecon_Other (1).pdfNovember 1, 2023637 KB
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127_Courtesy Copy_BLA 125742 0_CBER Sentinel Program Sufficiency Memo COMIRNATY.pdfNovember 1, 2023164 KB
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125_BLA 125742 0_08 23 2021_Memo_Committee Memo_Toxico.pdfNovember 1, 20234 MB
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124_BLA 125742 0_08 23 2021_Memo_Committee Memo_SBRA.pdfNovember 1, 20231 MB
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123_Courtesy Copy_BLA 125742 0_August 23, 2021 Approval Letter Comirnaty.pdfNovember 1, 2023157 KB
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122_BLA 125742 0_08 22 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023775 KB
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121_Courtesy Copy_BLA 125742 0_Employee Officer List Memo, August 22, 2021 COMIRNATY.pdfNovember 1, 202325 KB
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120_Courtesy Copy_BLA 125742 0_CBER CMC BLA Review Memo COMIRNATY.pdfNovember 1, 20231 MB
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119_Courtesy Copy_BLA 125742 0_Real World Evidence BLA Memo COMIRNATY.pdfNovember 1, 202363 KB
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118_1_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdfNovember 1, 2023659 KB
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117_2_BLA 125742 0_08 22 2021_Inspection Related_Inspect.pdfNovember 1, 20231 MB
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116_BLA 125742 0_08 21 2021_Inspection Related_Establi.pdfNovember 1, 20232 MB
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115_1_BLA 125742 0_08 21 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023789 KB
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111_BLA 125742 0_08 21 2021_Telecon_Advice.pdfNovember 1, 2023660 KB
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110_1_Courtesy Copy_BLA 125742 0_Analytical Method Review Memo COMIRNATY.pdfNovember 1, 2023308 KB
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109_Courtesy Copy_2_BLA 125742 0_CMC Review Memo, August 21, 2021 COMIRNATY.pdfNovember 1, 2023839 KB
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136_BLA_125742_RNAcontent_InSupportTesting.pdfNovember 1, 2023739 KB
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135_Courtesy Copy_BLA 125742 0_November 8, 2021_Summary Basis for Regulatory Action COMIRNATY.pdfNovember 1, 2023540 KB
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134_Courtesy Copy_BLA 125742 0_Toxicology Review COMIRNATY.pdfNovember 1, 20234 MB
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107_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023806 KB
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105_BLA 125742 0_08 20 2021_Telecon_Advice_Information.pdfNovember 1, 2023761 KB
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103_2_BLA 125742 0_08 20 2021_Memo_Test Results.pdfNovember 1, 20231 MB
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102_1_BLA 125742 0_08 20 2021_Memo_Test Results.pdfNovember 1, 20231 MB
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101_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Addendum Memo COMIRNATY.pdfNovember 1, 2023145 KB
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100A_BLA 125742 0_08 20 2021_Memo_Other.pdfNovember 1, 20231 MB
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100_BLA 125742 0_08 20 2021_Memo_Other.pdfNovember 1, 20231 MB
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99_BLA 125742 0_08 20 2021_Memo_Committee Memo_Labeli.pdfNovember 1, 20232 MB
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95_BLA 125742 0_08 19 2021_Memo_Compliance Check Acce.pdfNovember 1, 20232 MB
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94_Courtesy Copy_1_BLA 125742 0_Statistical Review COMIRNATY.pdfNovember 1, 2023261 KB
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93_Courtesy Copy_2_BLA 125742 0_Statistical Review COMIRNATY.pdfNovember 1, 2023301 KB
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92_BLA 125742 0_08 19 2021_Inspection Related_Inspect.pdfNovember 1, 20232 MB
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89_1_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdfNovember 1, 2023743 KB
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87_3_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
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86_BLA 125742 0_08 18 2021_Telecon_Advice.pdfNovember 1, 2023984 KB
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85_Courtesy Copy_BLA 125742 0_Statistical Review COMIRNATY.pdfNovember 1, 2023127 KB
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84_BLA 125742 0_08 18 2021_Memo_Committee Memo_Review.pdfNovember 1, 2023706 KB
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83_BLA 125742 0_08 17 2021_Telecon_Other.pdfNovember 1, 2023770 KB
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81_1_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdfNovember 1, 2023760 KB
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79_3_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdfNovember 1, 2023753 KB
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75_1_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdfNovember 1, 2023717 KB
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74_3_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdfNovember 1, 2023746 KB
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73_2_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
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68B_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023690 KB
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68A_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023710 KB
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68_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023753 KB
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66_4_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023794 KB
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65_BLA 125742 0_08 13 2021_Memo_Request For Complianc.pdfNovember 1, 2023864 KB
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64_Courtesy Copy_BLA 125742 0_Bioresearch Monitoring Discipline Review Memo, August 13, 2021 COMIRNATY.pdfNovember 1, 202381 KB
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62_BLA 125742 0_08 12 2021_Memo_Committee Memo_Requir.pdfNovember 1, 20231 MB
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108_BLA 125742 0_08 21 2021_Inspection Related_Inspect.pdfNovember 1, 20231 MB
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107A_1_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdfNovember 1, 2023815 KB
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47_1_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdfNovember 1, 2023755 KB
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46_2_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdfNovember 1, 2023789 KB
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45_BLA 125742 0_08 05 2021_Telecon_Advice.pdfNovember 1, 2023801 KB
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44_3_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdfNovember 1, 2023767 KB
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43A_STN 125742.0 4AUG21 LRP FU IR 2.pdfNovember 1, 20232 MB
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42_1_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdfNovember 1, 2023773 KB
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40_2_BLA 125742 0_08 03 2021_Telecon_Information Reques.pdfNovember 1, 2023772 KB
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39_2_BLA 125742 0_08 02 2021_Telecon_Information Reques.pdfNovember 1, 2023784 KB
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33_1_BLA 125742 0_07 27 2021_Telecon_Information Reques.pdfNovember 1, 2023734 KB
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32_1_BLA 125742 0_07 26 2021_Telecon_Information Reques.pdfNovember 1, 2023890 KB
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27_BLA 125742 0_07 19 2021_Telecon_Advice.pdfNovember 1, 2023746 KB
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26_2_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdfNovember 1, 2023789 KB
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25_1_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdfNovember 1, 2023794 KB
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21_BLA 125742 0_07 15 2021_Letter_Filing Notification.pdfNovember 1, 2023722 KB
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18_BLA 125742 0_07 09 2021_Telecon_Information Reques.pdfNovember 1, 2023765 KB
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15_BLA 125742 0_07 02 2021_Telecon_Information Reques.pdfNovember 1, 2023819 KB
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10_BLA 125742 11_12 22 2021_Memo_Committee Memo_CMC.pdfNovember 1, 2023757 KB
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9_IND_19736_491_29 Sep 2021_DEBORAH_DEBORAH__RO_ The Summary Monthly Safety Report has been reviewed. No furthe.pdfNovember 1, 2023716 KB
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8_IND_19736_453_26 Aug 2021_DEBORAH_DEBORAH__RO_.pdfNovember 1, 2023717 KB
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8_1_BLA 125742 0_06 25 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
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7_IND_19736_409_26 Jul 2021_DEBORAH_DEBORAH__RO_.pdfNovember 1, 2023718 KB
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6_IND_19736_366_24 Jun 2021_DEBORAH_DEBORAH__RO_.pdfNovember 1, 2023717 KB
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5_IND_19736_335_19 May 2021_DEBORAH_DEBORAH__RC_.pdfNovember 1, 2023716 KB
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4_IND_19736_289_27 Apr 2021_DEBORAH_DEBORAH__RC_.pdfNovember 1, 2023717 KB
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3_IND_19736_243_19 Mar 2021_KERRY_KERRY__RO_.pdfNovember 1, 2023696 KB
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3_BLA 125742 0_05 20 2021_Telecon_Information Reques.pdfNovember 1, 2023747 KB
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2_IND_19736_214_03 Mar 2021_KERRY_KERRY__RO_.pdfNovember 1, 2023698 KB
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1_IND_19736_185_23 Feb 2021_KERRY_KERRY__RO_.pdfNovember 1, 2023697 KB
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1_BLA 125742 0_05 13 2021_Letter_Acknowledgement Let.pdfNovember 1, 2023713 KB
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61_BLA 125742 0_08 11 2021_Telecon_Other.pdfNovember 1, 2023719 KB
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60_BLA 125742 0_08 11 2021_Telecon_Information Reques.pdfNovember 1, 2023764 KB
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58_2_BLA 125742 0_08 10 2021_Telecon_Information Reques.pdfNovember 1, 2023755 KB
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55_BLA 125742 0_08 09 2021_Telecon_Advice.pdfNovember 1, 20232 MB
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54_BLA 125742 0_08 09 2021_Inspection Related_Inspect.pdfNovember 1, 20231 MB
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53_2_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdfNovember 1, 2023765 KB
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52_1_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
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51_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Memo COMIRNATY.pdfNovember 1, 2023279 KB
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49_BLA 125742 0_08 06 2021_Letter_UNII Code Notificat.pdfNovember 1, 2023766 KB
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pd-production-110123.zipNovember 1, 2023337 MB
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md-production-110123.zipNovember 1, 202311 MB
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p1215d-production-110123.zipNovember 1, 202369 MB
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125742_S5_M3_requirements travel belgium.pdfOctober 1, 2023635 KB
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