Index of /ipfs/Qme2ahzN3BQmM1dN5pxsTK3MiPa5iPRnAD89roLVdf76Zh/Batch 19 - 3 Jan 2023
QmSj2EHsALGKv88YenPiUpRTNiHps4pc8cV1K1nRF7sQ2W
 1.1 GB
 
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106A_2_BLA_125742-0_08-20-2021_Telecon_Labeling via FAX_e.pdf
QmYN…FUGd
1.3 MB
 
10_BLA_125742-0_06-29-2021_Filing_Meeting_Summary.pdf
QmZP…7APY
730 kB
 
114A_2_BLA_125742-0_08-21-2021_Telecon_Labeling via FAX_e.pdf
QmaQ…HGMQ
1.4 MB
 
125742_S12_M1_13jul2021-response.pdf
QmR9…LShn
1.3 MB
 
125742_S12_M1_waiver-req-preservative.pdf
QmbJ…afqQ
727 kB
 
125742_S13_M5_5351_c4591001-adae-hiv-listing.pdf
QmPB…W8Kd
700 kB
 
125742_S13_M5_5351_c4591001-narrative-1226-12262255.pdf
QmRk…GfrC
641 kB
 
125742_S16_M1_ped-studies-deferral-track-change.pdf
QmPS…ig3X
680 kB
 
125742_S16_M1_psp-track.pdf
QmS3…zgee
944 kB
 
125742_S1_M5_5351_c4591001-interim-mth6-iec-irb-consent-form.pdf
QmQL…ddHL
11 MB
 
125742_S21_M1_pharmacovigilance-plan.pdf
QmXh…uFw7
14 MB
 
125742_S21_M1_pvp-track.pdf
QmTU…x6FX
8.7 MB
 
125742_S27_M1_response-29jul2021.pdf
QmXd…dutX
1.4 MB
 
125742_S28_M1_response-22jul2021-followup.pdf
QmP7…9Xts
786 kB
 
125742_S29_M1_lab-1448-0-2-annotated.pdf
QmNW…zEHG
3.1 MB
 
125742_S29_M1_lab-1448-0-2-pkg-insert-clean.pdf
QmPn…dn4d
1.3 MB
 
125742_S29_M1_lab-1448-0-2-pkg-insert-track.pdf
QmT5…me1L
1.5 MB
 
125742_S33_M5_5351_c4591001-508-efficacy-tables.pdf
Qmeb…W6FY
841 kB
 
125742_S38_M5_c4591001-508-safety-tables.pdf
QmWx…v8eY
951 kB
 
125742_S39_M1_5351_c4591001-ve-tables.pdf
Qmd5…mUEK
712 kB
 
125742_S39_M1_lab-1448-0-3-annotated.pdf
QmWr…TvbA
6.3 MB
 
125742_S39_M1_lab-1448-0-3-pkg-insert-clean.pdf
QmYN…vthm
5.0 MB
 
125742_S39_M1_lab-1448-0-3-pkg-insert-track.pdf
Qmev…RZNs
5.2 MB
 
125742_S41_M1_c4591001-ve-tables.pdf
QmTH…h2ay
712 kB
 
125742_S46_M1_carton-com195lkz-kzoo.pdf
QmfU…U1Sh
144 kB
 
125742_S46_M1_carton-com195lpus-puurs.pdf
Qmep…gFva
183 kB
 
125742_S46_M1_carton-com25ctkz-kzoo.pdf
QmVT…vKzt
222 kB
 
125742_S46_M1_carton-com25ctpus-puurs.pdf
QmPE…V5xT
247 kB
 
125742_S46_M1_label-comvlabkz-kzoo.pdf
QmaW…qmCp
50 kB
 
125742_S46_M1_label-comvlabp-puurs.pdf
QmUU…nDSM
56 kB
 
125742_S46_M1_sticker-comdilrm.pdf
QmUT…qdPe
58 kB
 
125742_S51_M1_lab-1448-0-4-annotated.pdf
QmVC…5arV
4.1 MB
 
125742_S51_M1_lab-1448-0-4-pkg-insert-clean.pdf
QmUQ…AzQu
1.2 MB
 
125742_S51_M1_lab-1448-0-4-pkg-insert-track.pdf
QmVV…SrqM
1.3 MB
 
125742_S51_M5_5351_c4591001-followup-table.pdf
QmVs…2pas
621 kB
 
125742_S54_M1_carton-com195lkz-kzoo.pdf
QmbX…XbXy
138 kB
 
125742_S54_M1_carton-com195lpus-puurs.pdf
QmRc…wR69
183 kB
 
125742_S54_M1_carton-com25ctkz-kzoo.pdf
QmTx…JFFc
224 kB
 
125742_S54_M1_carton-com25ctpus-puurs.pdf
QmXk…2P8K
708 kB
 
125742_S58_M1_lab-1448-0-5-annotated.pdf
Qmde…BLk1
3.1 MB
 
125742_S58_M1_lab-1448-0-5-pkg-insert-clean.pdf
QmT4…9hUM
899 kB
 
125742_S58_M1_lab-1448-0-5-pkg-insert-track.pdf
Qmf3…U29R
901 kB
 
125742_S64_M1_carton-com195lkz-kzoo.pdf
QmWt…XyMJ
138 kB
 
125742_S64_M1_carton-com195lpus-puurs.pdf
QmZm…s6av
182 kB
 
125742_S64_M1_carton-com25ctkz-kzoo.pdf
QmWR…bdoA
222 kB
 
125742_S64_M1_carton-com25ctpus-puurs.pdf
Qmbt…Yrj2
248 kB
 
125742_S64_M1_label-comvlabkz-kzoo.pdf
QmeU…sHPx
50 kB
 
125742_S64_M1_label-comvlabp-puurs.pdf
Qmck…RHLm
664 kB
 
125742_S64_M1_sticker-comdilrm.pdf
QmTN…MF4Z
184 kB
 
125742_S68_M1_lab-1448-0-6-annotated.pdf
QmWf…dmXJ
3.1 MB
 
125742_S68_M1_lab-1448-0-6-pkg-insert-clean.pdf
QmXg…oZDQ
1.1 MB
 
125742_S68_M1_lab-1448-0-6-pkg-insert-track.pdf
QmeP…JWzn
1.1 MB
 
125742_S6_M5_5351_c4591001-sequencing-listings.pdf
QmP8…1Lxw
3.9 MB
 
125742_S70_M1_lab-1448-0-7-annotated.pdf
QmYH…MaHM
1.6 MB
 
125742_S70_M1_lab-1448-0-7-pkg-insert-clean.pdf
QmeV…Gq9j
1.1 MB
 
125742_S70_M1_lab-1448-0-7-pkg-insert-track.pdf
QmYP…ekWp
1.1 MB
 
125742_S73_M1_lab-1448-0-8-annotated.pdf
QmXr…Ls3R
3.1 MB
 
125742_S73_M1_lab-1448-0-8-pkg-insert-clean.pdf
QmaF…tJYh
1.1 MB
 
125742_S73_M1_lab-1448-0-8-pkg-insert-track.pdf
QmU7…y4tx
1.1 MB
 
125742_S76_M1_lab-1448-0-9-annotated.pdf
QmTk…fDSo
1.4 MB
 
125742_S76_M1_lab-1448-0-9-pkg-insert-clean.pdf
QmQ9…Hm4L
1.1 MB
 
125742_S76_M1_lab-1448-0-9-pkg-insert-track.pdf
QmR3…a5BA
1.1 MB
 
125742_S79_M1_lab-1448-1-0-pkg-insert-clean.pdf
Qmc2…7K8g
896 kB
 
125742_S7_M1_response-08jun2021.pdf
Qmex…SsCF
1.4 MB
 
125742_S80_M1_lab-1448-1-0-pkg-insert-clean.pdf
QmRf…keAr
896 kB
 
126_BLA 125742-0_08-23-2021_Memo_Other.pdf
QmYH…o6AE
664 kB
 
130_BLA _125742-0_09-01-2021_Committee Memo_Labeling.pdf
QmdJ…Qarj
790 kB
 
13_BLA_125742-0_07-02-2021_Committee Memo_APLB.pdf
Qmbm…P3bH
869 kB
 
36A_BLA_125742-0_07-28-2021_Telecon_Labeling Target Cl.pdf
QmRb…yg2B
1.4 MB
 
4_BLA_125742-0_06-03-2021_First_Committee_Meeting_Summary.pdf
QmU9…BRDe
791 kB
 
72A_BLA_125742-0_08-13-2021_Telecon_Labeling via FAX_e.pdf
Qmbk…v2qV
1.4 MB
 
77_BLA_125742-0_08-17-2021_Memo_Lot Release Clearance.pdf
QmZt…nZoA
824 kB
 
78_BLA_125742-0_08-17-2021_Memo_Other.pdf
QmUb…pfoq
834 kB
 
7_BLA_125742-0_06-17-2021_Memo_Other.pdf
QmeF…UYrW
699 kB
 
82A_BLA_125742-0_08-17-2021_Telecon_Labeling via FAX_e.pdf
QmaR…d23E
1.3 MB
 
91A_2_BLA_125742-0_08-18-2021_Telecon_Labeling via FAX_e.pdf
QmeJ…bqJ2
1.3 MB
 
98A_BLA_125742-0_08-19-2021_Telecon_Labeling via FAX_e.pdf
Qmb2…E97U
1.3 MB
 
FDA-CBER-2021-5683-0652385-0652413-125742_S29_M1_lab-1448-0-2-pkg-insert-clean.docx
QmZP…jWCT
548 kB
 
FDA-CBER-2021-5683-0652414-0652442-125742_S29_M1_lab-1448-0-2-pkg-insert-track.doc
QmR3…k4ru
556 kB
 
FDA-CBER-2021-5683-0652443-0652471-125742_S33_M5_5351_c4591001-508-efficacy-tables.doc
Qmad…7xHC
58 kB
 
FDA-CBER-2021-5683-0652472-0652503-125742_S38_M5_c4591001-508-safety-tables.doc.docx
QmPF…mcdB
75 kB
 
FDA-CBER-2021-5683-0652504-0652525-125742_S39_M1_lab-1448-0-3-pkg-insert-track.doc
Qmdv…BZZb
1.0 MB
 
FDA-CBER-2021-5683-0652526-0652547-125742_S39_M1_lab-1448-0-3-annotated.doc
QmSw…cetE
1.1 MB
 
FDA-CBER-2021-5683-0652548-0652569-125742_S39_M1_lab-1448-0-3-pkg-insert-clean.doc
QmWx…bUVe
778 kB
 
FDA-CBER-2021-5683-0652570-0652590-125742_S51_M1_lab-1448-0-4-pkg-insert-track.docx
QmXb…f4yM
535 kB
 
FDA-CBER-2021-5683-0652591-0652611-125742_S51_M1_lab-1448-0-4-annotated.docx
QmUq…bZew
552 kB
 
FDA-CBER-2021-5683-0652612-0652632-125742_S51_M1_lab-1448-0-4-pkg-insert-clean.docx
QmPD…bAvW
526 kB
 
FDA-CBER-2021-5683-0652633-0652652-125742_S58_M1_lab-1448-0-5-annotated.docx
QmfY…ePkK
536 kB
 
FDA-CBER-2021-5683-0652653-0652672-125742_S58_M1_lab-1448-0-5-pkg-insert-track.docx
QmYK…Cumo
526 kB
 
FDA-CBER-2021-5683-0652673-0652692-125742_S58_M1_lab-1448-0-5-pkg-insert-clean.docx
QmUE…n6CV
526 kB
 
FDA-CBER-2021-5683-0652693-0652713-125742_S68_M1_lab-1448-0-6-annotated.docx
QmUT…qk3f
533 kB
 
FDA-CBER-2021-5683-0652714-0652734-125742_S68_M1_lab-1448-0-6-pkg-insert-clean.docx
QmZZ…35uz
527 kB
 
FDA-CBER-2021-5683-0652735-0652755-125742_S68_M1_lab-1448-0-6-pkg-insert-track.docx
Qmas…3Z8p
527 kB
 
FDA-CBER-2021-5683-0652756-0652776-125742_S70_M1_lab-1448-0-7-annotated.docx
QmY7…RANC
533 kB
 
FDA-CBER-2021-5683-0652777-0652797-125742_S70_M1_lab-1448-0-7-pkg-insert-clean.docx
QmPx…43k7
535 kB
 
FDA-CBER-2021-5683-0652798-0652818-125742_S70_M1_lab-1448-0-7-pkg-insert-track.docx
QmYU…DdBb
528 kB
 
FDA-CBER-2021-5683-0652819-0652838-125742_S73_M1_lab-1448-0-8-pkg-insert-clean.docx
Qmdz…dgCW
527 kB
 
FDA-CBER-2021-5683-0652839-0652858-125742_S73_M1_lab-1448-0-8-annotated.docx
Qmcw…mWZ2
533 kB
 
FDA-CBER-2021-5683-0652859-0652878-125742_S73_M1_lab-1448-0-8-pkg-insert-track.docx
QmYU…Xs4x
528 kB
 
FDA-CBER-2021-5683-0652879-0652898-125742_S76_M1_lab-1448-0-9-pkg-insert-clean.docx
QmaN…gYYi
527 kB
 
FDA-CBER-2021-5683-0652899-0652919-125742_S76_M1_lab-1448-0-9-pkg-insert-track.docx
QmTV…c4DV
527 kB
 
FDA-CBER-2021-5683-0652920-0652940-125742_S76_M1_lab-1448-0-9-annotated.docx
QmQR…VJz5
531 kB
 
FDA-CBER-2021-5683-0652941-0652960-125742_S79_M1_lab-1448-1-0-pkg-insert-clean.docx
QmQ2…qKak
527 kB
 
FDA-CBER-2021-5683-0652961-0652980-125742_S80_M1_lab-1448-1-0-pkg-insert-clean.docx
Qmf7…zbRy
527 kB
 
FDA-CBER-2021-5683-0652981-0654506-125742_S1_M5_bnt162-01-A-D-adlb.xpt
QmQi…7pAM
81 MB
 
FDA-CBER-2021-5683-0654507-0658059-125742_S1_M5_bnt162-01-S-Supp-D-suppface.xpt
QmVc…SNTw
14 MB
 
FDA-CBER-2021-5683-0658060-0661613-125742_S1_M5_bnt162-01-S-D-face.xpt.xpt
QmZR…uwKo
78 MB
 
FDA-CBER-2021-5683-0661614-0663134-125742_S1_M5_bnt162-01-S-D-lb.xpt
QmWd…FzfS
26 MB
 
FDA-CBER-2021-5683-0663135-0671344-125742_S1_M5_c4591001-A-D-adsympt.xpt
Qmcq…fQ1m
206 MB
 
FDA-CBER-2021-5683-0671345-0674997-125742_S1_M5_c4591001-S-D-supplb.xpt
QmRt…S2Yr
17 MB
 
FDA-CBER-2021-5683-0674998-0678267-125742_S1_M5_c4591001-S-Supp-D-suppmb.xpt
Qmdq…f6T1
21 MB
 
FDA-CBER-2021-5683-0678268-0681345-125742_S1_M5_c4591001-A-D-adds.xpt
QmfM…Qcdh
208 MB
 
FDA-CBER-2021-5683-0681346-0688437-125742_S1_M5_c4591001-S-D-ds.xpt
QmfX…cwSm
78 MB
 
FDA-CBER-2021-5683-0688438-0698919-125742_S1_M5_c4591001-S-D-vs.xpt
QmRc…UeFt
183 MB
 
FDA-CBER-2021-5683-0698920-0703842-125742_S1_M5_c4591001-S-D-suppae.xpt
QmVY…V8BX
40 MB
 
FDA-CBER-2021-5683-0703843-0708840-125742_S1_M5_c4591001-S-Supp-D-suppae.xpt
QmfS…Rrdf
41 MB