TitleDateFile SizeLink
md-production-040124.zipApril 1, 2024172 MB
md-production-030124.zipMarch 1, 2024125 MB
md-production-020124.zipFebruary 1, 2024330 MB
md-production-010224.zipJanuary 2, 2024220 MB
p1215d-production-010224.zipJanuary 2, 2024194 MB
md-production-120423.zipDecember 4, 2023103 MB
p1215d-production-120423.zipDecember 4, 2023568 MB
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125742_S111_M1_356h.pdfNovember 1, 20234 MB
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125742_S57_M3_32p3_manufacturer diluent.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
FDA CBER 2021 5683 1150835 1200874_Slipsheet.pdfNovember 1, 202369 KB
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125742_S50_M3_32r_comirnaty lot release template.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_S11_M3_32r_pf 07302048 dp rm coa.pdfNovember 1, 2023634 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_677159p 1g a 010 coa.pdfNovember 1, 2023636 KB
125742_S11_M3_32r_677100p 1g a 010 coa.pdfNovember 1, 2023636 KB
125742_S11_M3_32r_21y513c2501 coa.pdfNovember 1, 2023636 KB
125742_S11_M3_32r_21y513c2401 coa.pdfNovember 1, 20231 MB
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125742_S5_M1_response 20 may 2021 facilities.pdfNovember 1, 20231 MB
125742_S5_M1_cover.pdfNovember 1, 2023725 KB
125742_S2_M3_32s4_validation analyt procedure overview.pdfNovember 1, 20232 MB
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125742_S2_M3_32s4_analytical procedure overview.pdfNovember 1, 20232 MB
125742_S34_M1_cover.pdfNovember 1, 2023668 KB
125742_S30_M1_response 26jul2021.pdfNovember 1, 20231 MB
125742_S2_M3_32r_reg info manufacturing schedules.pdfNovember 1, 20232 MB
125742_S2_M3_32r_reg info lot release documentation package.pdfNovember 1, 20234 MB
125742_S2_M3_32p53_validation analytical procedures overview.pdfNovember 1, 20232 MB
125742_S2_M3_32p53_validation analytical procedure rt pcr.pdfNovember 1, 20232 MB
125742_S2_M3_32p53_validation analytical procedure cap gel electro.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure subvis particulate matter.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure rt pcr.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure overview.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure osmometry.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure endotoxin.pdfNovember 1, 20232 MB
125742_S2_M3_32p52_analytical procedure cap gel electro.pdfNovember 1, 20232 MB
125742_S2_M3_32p8_stability summary.pdfNovember 1, 20232 MB
125742_S2_M3_32p8_stability data thermal stress cycling.pdfNovember 1, 20233 MB
125742_S2_M3_32p8_stability data photostability.pdfNovember 1, 20232 MB
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125742_S2_M3_32p8_stability data accelerated.pdfNovember 1, 20232 MB
125742_S2_M3_32p8_postapproval stability.pdfNovember 1, 20232 MB
125742_S2_M3_32p5_specifications.pdfNovember 1, 20232 MB
125742_S2_M3_32p5_batch analyses.pdfNovember 1, 20233 MB
125742_S2_M3_32p4_novel excipients.pdfNovember 1, 20232 MB
125742_S2_M3_32p4_excipients human animal.pdfNovember 1, 20232 MB
125742_S2_M3_32p3_manufacturers.pdfNovember 1, 20232 MB
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125742_S2_M3_32p3_batch formula.pdfNovember 1, 20232 MB
125742_S2_M3_32p2_pharmaceutical development 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 description composition drug prod.pdfNovember 1, 20232 MB
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125742_S1_M1_financial cert 3455.pdfNovember 1, 20232 MB
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125742_S1_M1_1.9.2_ped studies deferral req.pdfNovember 1, 202311 MB
138_BLA_125742_STN125742 release test (pH) lots FD7220, FE3592, FF2587.pdfNovember 1, 20231 MB
137_BLA_125742_Endotoxin release tests lots FD7220, FE3592, FF2587.pdfNovember 1, 2023813 KB
125742_S2_M3_32s2_manufacturer.pdfNovember 1, 20232 MB
125742_S2_M3_32s2_control critical steps manuf process.pdfNovember 1, 20232 MB
133_Courtesy Copy_BLA 125742 0_Benefit Risk Assessment Review Memo COMIRNATY.pdfNovember 1, 20233 MB
132_BLA 125742 0_09 13 2021_Memo_Committee Memo_Review (1).pdfNovember 1, 20231 MB
131_Courtesy Copy_BLA 125742 0_Clinical Review Memo, August 23, 2021 COMIRNATY.pdfNovember 1, 20231 MB
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128_BLA 125742 0_08 30 2021_Telecon_Other (1).pdfNovember 1, 2023637 KB
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125_BLA 125742 0_08 23 2021_Memo_Committee Memo_Toxico.pdfNovember 1, 20234 MB
124_BLA 125742 0_08 23 2021_Memo_Committee Memo_SBRA.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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111_BLA 125742 0_08 21 2021_Telecon_Advice.pdfNovember 1, 2023660 KB
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136_BLA_125742_RNAcontent_InSupportTesting.pdfNovember 1, 2023739 KB
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102_1_BLA 125742 0_08 20 2021_Memo_Test Results.pdfNovember 1, 20231 MB
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92_BLA 125742 0_08 19 2021_Inspection Related_Inspect.pdfNovember 1, 20232 MB
89_1_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdfNovember 1, 2023743 KB
87_3_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
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81_1_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdfNovember 1, 2023760 KB
79_3_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdfNovember 1, 2023753 KB
75_1_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdfNovember 1, 2023717 KB
74_3_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdfNovember 1, 2023746 KB
73_2_BLA 125742 0_08 16 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
68B_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023690 KB
68A_5_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023710 KB
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66_4_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdfNovember 1, 2023794 KB
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47_1_BLA 125742 0_08 05 2021_Telecon_Information Reques.pdfNovember 1, 2023755 KB
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45_BLA 125742 0_08 05 2021_Telecon_Advice.pdfNovember 1, 2023801 KB
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43A_STN 125742.0 4AUG21 LRP FU IR 2.pdfNovember 1, 20232 MB
42_1_BLA 125742 0_08 04 2021_Telecon_Information Reques.pdfNovember 1, 2023773 KB
40_2_BLA 125742 0_08 03 2021_Telecon_Information Reques.pdfNovember 1, 2023772 KB
39_2_BLA 125742 0_08 02 2021_Telecon_Information Reques.pdfNovember 1, 2023784 KB
33_1_BLA 125742 0_07 27 2021_Telecon_Information Reques.pdfNovember 1, 2023734 KB
32_1_BLA 125742 0_07 26 2021_Telecon_Information Reques.pdfNovember 1, 2023890 KB
27_BLA 125742 0_07 19 2021_Telecon_Advice.pdfNovember 1, 2023746 KB
26_2_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdfNovember 1, 2023789 KB
25_1_BLA 125742 0_07 16 2021_Telecon_Information Reques.pdfNovember 1, 2023794 KB
21_BLA 125742 0_07 15 2021_Letter_Filing Notification.pdfNovember 1, 2023722 KB
18_BLA 125742 0_07 09 2021_Telecon_Information Reques.pdfNovember 1, 2023765 KB
15_BLA 125742 0_07 02 2021_Telecon_Information Reques.pdfNovember 1, 2023819 KB
10_BLA 125742 11_12 22 2021_Memo_Committee Memo_CMC.pdfNovember 1, 2023757 KB
9_IND_19736_491_29 Sep 2021_DEBORAH_DEBORAH__RO_ The Summary Monthly Safety Report has been reviewed. No furthe.pdfNovember 1, 2023716 KB
8_IND_19736_453_26 Aug 2021_DEBORAH_DEBORAH__RO_.pdfNovember 1, 2023717 KB
8_1_BLA 125742 0_06 25 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
7_IND_19736_409_26 Jul 2021_DEBORAH_DEBORAH__RO_.pdfNovember 1, 2023718 KB
6_IND_19736_366_24 Jun 2021_DEBORAH_DEBORAH__RO_.pdfNovember 1, 2023717 KB
5_IND_19736_335_19 May 2021_DEBORAH_DEBORAH__RC_.pdfNovember 1, 2023716 KB
4_IND_19736_289_27 Apr 2021_DEBORAH_DEBORAH__RC_.pdfNovember 1, 2023717 KB
3_IND_19736_243_19 Mar 2021_KERRY_KERRY__RO_.pdfNovember 1, 2023696 KB
3_BLA 125742 0_05 20 2021_Telecon_Information Reques.pdfNovember 1, 2023747 KB
2_IND_19736_214_03 Mar 2021_KERRY_KERRY__RO_.pdfNovember 1, 2023698 KB
1_IND_19736_185_23 Feb 2021_KERRY_KERRY__RO_.pdfNovember 1, 2023697 KB
1_BLA 125742 0_05 13 2021_Letter_Acknowledgement Let.pdfNovember 1, 2023713 KB
61_BLA 125742 0_08 11 2021_Telecon_Other.pdfNovember 1, 2023719 KB
60_BLA 125742 0_08 11 2021_Telecon_Information Reques.pdfNovember 1, 2023764 KB
58_2_BLA 125742 0_08 10 2021_Telecon_Information Reques.pdfNovember 1, 2023755 KB
55_BLA 125742 0_08 09 2021_Telecon_Advice.pdfNovember 1, 20232 MB
54_BLA 125742 0_08 09 2021_Inspection Related_Inspect.pdfNovember 1, 20231 MB
53_2_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdfNovember 1, 2023765 KB
52_1_BLA 125742 0_08 06 2021_Telecon_Information Reques.pdfNovember 1, 20231 MB
51_Courtesy Copy_BLA 125742 0_Pharmacovigilance Plan Review Memo COMIRNATY.pdfNovember 1, 2023279 KB
49_BLA 125742 0_08 06 2021_Letter_UNII Code Notificat.pdfNovember 1, 2023766 KB
pd-production-110123.zipNovember 1, 2023337 MB
md-production-110123.zipNovember 1, 202311 MB
p1215d-production-110123.zipNovember 1, 202369 MB
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3_PM_S89_BLA 125742 5_09 21 2021_Telecon_Other.pdfOctober 1, 2023724 KB
19736_S0243_M1_cover.pdfOctober 1, 2023733 KB
19736_S0335_M1_cover.pdfOctober 1, 2023735 KB
19736_S0408_M1_cover.pdfOctober 1, 2023736 KB
19736_S0366_M1_cover.pdfOctober 1, 2023736 KB
19736_S0453_M1_cover.pdfOctober 1, 2023739 KB
125742_2_BLA 125742 0_05 18 2021_Telecon_Information Reques.pdfOctober 1, 2023742 KB
19736_S0491_M1_cover.pdfOctober 1, 2023742 KB
125742_S2_M5_5.4_who 2005.pdfOctober 1, 2023747 KB
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019736_S444_M5_c4591007 p2 3 older child assent lower dose eval.pdfOctober 1, 2023773 KB
5_PM_S102_1_BLA 125742 8_09 21 2021_Memo_600.81 Lot Distributi.pdfOctober 1, 2023782 KB
6_PM_S102_2_BLA 125742 8_09 21 2021_Memo_600.81 Lot Distributi.pdfOctober 1, 2023783 KB
019736_S444_M5_c4591007 p1 older children assent lower dose eval icd.pdfOctober 1, 2023786 KB
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125742_S2_M1_356h.pdfOctober 1, 2023813 KB
019736_S387_M5_c4591008 interim sponsor signature.pdfOctober 1, 2023824 KB
19736_S0185_M1_1571.pdfOctober 1, 2023827 KB
7_PM_S102_BLA 125742 8_09 29 2021_Letter_Waiver Request.pdfOctober 1, 2023830 KB
11_PM_S136_BLA 125742 31_10 30 2021_Memo_Final Review Memo.pdfOctober 1, 2023835 KB
019736_S488_M5_c4591007 p2 3 older children assent troponin icd.pdfOctober 1, 2023837 KB
019736_S222_M5_c4591020 informed consent form.pdfOctober 1, 2023867 KB
019736_S488_M5_c4591007 p2 3 parent icd pbo controlled selected dose.pdfOctober 1, 2023880 KB
9_PM_S105_BLA 125742 9_09 20 2021_Telecon_Advice.pdfOctober 1, 2023941 KB
019736_S444_M5_c4591007 p2 3 adult participant icd lower dose eval.pdfOctober 1, 2023966 KB
019736_S444_M5_c4591007 p1 adult participant icd lower dose eval.pdfOctober 1, 2023974 KB
4_PM_S89_BLA 125742 5_09 22 2021_Telecon_Advice.pdfOctober 1, 2023983 KB
019736_S444_M5_c4591007 p2 3 parent icd lower dose eval.pdfOctober 1, 2023988 KB
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019736_S488_M5_c4591007 p2 3 younger children assent troponin icd.pdfOctober 1, 20231,013 KB
1_PM_S85_BLA 125742 4_09 30 2021_Telecon_Advice.pdfOctober 1, 20231,014 KB
8_PM_S102_BLA 125742 8_09 29 2021_Telecon_Other.pdfOctober 1, 20231,016 KB
019736_S70_M5_vr sop lc 11120.pdfOctober 1, 20231,020 KB
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019736_S268_M5_wi255886 sap.pdfOctober 1, 20231 MB
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019736_S387_M5_c4591008 interim sample icd.pdfOctober 1, 20231 MB
019736_S444_M5_c4591007 p2 3 younger child assent lower dose eval.pdfOctober 1, 20231 MB
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125742_S1_M5_5351_c4591001 fa interim investigators.pdfOctober 1, 20232 MB
125742_S1_M5_5351_c4591001 interim mth6 investigators.pdfOctober 1, 20232 MB
019736_S387_M5_c4591008 interim non hospitalization.pdfOctober 1, 20232 MB
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019736_S444_M5_c4591007 p1 younger children assent lower dose eval icd.pdfOctober 1, 20232 MB
019736_S387_M5_c4591008 interim demographics.pdfOctober 1, 20232 MB
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019736_S488_M5_c4591007 p2 3 parent addendum icd pbo cont selected dose.pdfOctober 1, 20232 MB
125742_S6_M5_5351_c4591001 sequencing report.pdfOctober 1, 20232 MB
019736_S222_M5_c4591020 protocol.pdfOctober 1, 20231 MB
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019736_S387_M5_c4591012 interim abstract.pdfOctober 1, 20233 MB
125742_S2_M5_5.4_sedic m 2020.pdfOctober 1, 20233 MB
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125742_S1_M5_5351_c4591001 fa interim interlab standard.pdfOctober 1, 20233 MB
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019736_S387_M5_c4591008 interim protocol.pdfOctober 1, 20234 MB
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019736_S470_M5_c4591012 protocol.pdfOctober 1, 20234 MB
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125742_S2_M5_5.4_singh dk 2020.pdfOctober 1, 20238 MB
19736_S0185_M1_smsr 01dec2020 31dec2020.pdfOctober 1, 20239 MB
019736_S387_M1_cover.pdfOctober 1, 202311 MB
019736_S196_M5_c4591012 protocol.pdfOctober 1, 202313 MB
19736_S0214_M1_smsr 01jan2021 31jan2021.pdfOctober 1, 202315 MB
019736_S268_M5_wi235284 protocol.pdfOctober 1, 202316 MB
019736_S414_M5_c4591001 amendment 17 clean.pdfOctober 1, 202316 MB
019736_S414_M5_c4591001 amendment 17 track.pdfOctober 1, 202316 MB
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019736_S387_M5_c4591012 interim report body.pdfOctober 1, 20235 MB
019736_S387_M5_c4591008 interim report body.pdfOctober 1, 20236 MB
019736_S387_M5_c4591008 interim compliance.pdfOctober 1, 20237 MB
019736_S488_M5_c4591007 protocol amend3 track.pdfOctober 1, 202323 MB
19736_S0369 dsur 22apr2020 21apr2021.pdfOctober 1, 202323 MB
019736_S444_M5_c4591007 protocol amend2 track.pdfOctober 1, 202323 MB
019736_S444_M5_c4591007 protocol amend2.pdfOctober 1, 202324 MB
19736_S0243 smsr 01feb2021 28feb2021.pdfOctober 1, 202331 MB
19736_S0289_M1_smsr 01mar2021 31mar2021.pdfOctober 1, 202337 MB
125742_S1_M1_meeting correspondence.pdfOctober 1, 202321 MB
019736_S488_M5_c4591007 protocol amend3.pdfOctober 1, 202322 MB
125742_S1_M5_5351_bnt162 01 interim3 reports.pdfOctober 1, 202373 MB
19736_S0408_M1_smsr 01jun2021 30jun2021.pdfOctober 1, 202376 MB
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19736_S0366_M1_smsr 30apr2021 31may2021.pdfOctober 1, 202367 MB
19736_S0491_M1_smsr-01aug2021-31aug2021.pdfOctober 1, 2023100 MB
19736_S0453_M1_smsr-01jul2021-31jul2021.pdfOctober 1, 2023100 MB
125742_S0136_M5_smsr-01sep2021-30sep2021.pdfOctober 1, 2023112 MB
pd-production-100123.zipOctober 1, 20231.3 GB
p1215d-production-100123.zipOctober 1, 202388 MB
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FDA CBER 2022 5812 0099773 0107915_125742 45_S211_M5_c4591001 S_1mth D_suppvs.zip (xpt)September 1, 2023917 KB
FDA CBER 2022 5812 0089294 0099772_125742 45_S211_M5_c4591001 S_1mth D_vs.zip (xpt)September 1, 20238 MB
FDA CBER 2022 5812 0082642 0089293_125742 45_S211_M5_c4591001 S_1mth D_sv.zip (xpt)September 1, 20232 MB
FDA CBER 2022 5812 0073164 0082641_125742 45_S211_M5_c4591001 S_1mth D_ce.zip (xpt)September 1, 20239 MB
125752_S1_M4.3_oh 2012.pdfSeptember 1, 20233 MB
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FDA CBER 2021 5683 1007277_125742_S2_M1_comirnaty 05.jpgAugust 1, 202310 KB
FDA CBER 2021 5683 1007276_125742_S2_M1_comirnaty 04.jpgAugust 1, 202319 KB
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FDA CBER 2021 5683 1007314 1007337_125742_S82_M1_comirnaty.xmlAugust 1, 2023139 KB
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125742_S65_M1_pp cvv usa 0349 01.pdfAugust 1, 202360 MB
FDA CBER 2021 5683 1007349_125742_S138_M1_pp cvv usa 0416.mp3August 1, 2023243 KB
mp1215d-production-070323.zipJuly 3, 202312 MB
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