137 BLA 125742 Endotoxin release tests lots FD7220 FE3592 FF2587

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

6

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James L. Kenney -SDigitally signed by James L  Kenney S 
DN: c US  o U S  Government  ou HHS  ou FDA  ou People  0 9 2342 19200300 100 1 1 1300431652  cn James L  Kenney S Date: 2021 08 18 15:12 10 04 00'
Nadine S. Kaelber -SDigitally signed by Nadine S. Kaelber -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2002096592, cn=Nadine S. Kaelber -S Date: 2021.08.18 17:31:14 -04 00
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FDA-CBER-2021-5683-1150740
James L. Kenney -SDigitally signed by James L. Kenney -S 
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300431652, cn=James L. Kenney -S Date: 2021.08.18 17:15:34 -04'00'
Nadine S. Kaelber -SDigitally signed by Nadine S. Kaelber -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2002096592, cn=Nadine S. Kaelber -S Date: 2021.08.18 17:31:57 -04'00'
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FDA-CBER-2021-5683-1150741
James L. Kenney -SDigitally signed by James L. Kenney -S 
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300431652, cn=James L. Kenney -S Date: 2021.08.18 17:16:12 -04'00'
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FDA-CBER-2021-5683-1150742
James L. Kenney -SDigita ly signed by James L  Kenney S 
DN: c=US  o=U S  Government  ou=HHS  ou=FDA  ou=People  0 9 2342 19200300 100 1 1=1300431652  cn=James L  Kenney S Date: 2021 08 18 17:16:43 04'00'
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FDA-CBER-2021-5683-1150743
James L. Kenney -SDigitally signed by James L. Kenney -S 
DN: c=US, o=U S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300431652, cn=James L. Kenney -S Date: 2021.08.18 17:17:17 -04'00'
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FDA-CBER-2021-5683-1150744
James L. Kenney -SDigitally signed by James L. Kenney -S 
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300431652, cn=James L. Kenney -S Date: 2021.08.18 17:17:59 -04'00'
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FDA-CBER-2021-5683-1150745