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Drug Review Package Fuzeon (enfuvirtide) for injection Company: Hoffman-LaRoche, Inc. Application No.: 021481 Approval Date: 3/13/2003 Approval Letter(s) (PDF) Printed Labeling (PDF) Medical Review(s) (PDF) Chemistry Review(s) (PDF) Clinical Review Part 1 Part 2 Part 3 Pharmacology Review(s) (PDF) Part 1 (PDF) Part 2 (PDF) Part 3 (PDF) Part 4 (PDF) Statistical Review(s) (PDF) Microbiology Review(s) (PDF) Clinical Pharmacology Biopharmaceutics Review(s) (PDF) Part 1 (PDF) Part 2 (PDF) Part 3 (PDF) Administrative Document(s) & Correspondence (PDF) Part 1 (PDF) Part 2 (PDF) Part 3 (PDF) Date created: July 23, 2003 Back to Top Drugs@FDA7 |
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- ¸½¼þ 2 : 0.Labeling_Revision___2012.pdf
- ¸½¼þ 3 : 0.Letter_(PDF).pdf
- ¸½¼þ 4 : 1.Approval_Letter(s)_(PDF).pdf
- ¸½¼þ 5 : 2.Printed_Labeling_(PDF).pdf
- ¸½¼þ 6 : 3.Medical_Review(s)_(PDF).pdf
- ¸½¼þ 7 : 4.Chemistry_Review(s)_(PDF).pdf
- ¸½¼þ 8 : 5.1_Clinical_Review_part_1.pdf
- ¸½¼þ 9 : 5.2_Clinical_Review_part_2.pdf
- ¸½¼þ 10 : 5.3_Clinical_Review_part_3.pdf
- ¸½¼þ 11 : 6.1Pharmacology_Review(s)_(PDF)_part_1.pdf
- ¸½¼þ 12 : 6.2_Pharmacology_Review(s)_(PDF)_part_2.pdf
- ¸½¼þ 13 : 6.3Pharmacology_Review(s)_(PDF)_part_3.pdf
- ¸½¼þ 14 : 6.4Pharmacology_Review(s)_(PDF)_part_4.pdf
- ¸½¼þ 15 : 7.Statistical_Review(s)_(PDF).pdf
- ¸½¼þ 16 : 8.Microbiology_Review(s)_(PDF).pdf
- ¸½¼þ 17 : 9.1_Clinical_Pharmacology_Biopharmaceutics_Review(s)_(PDF)__1.pdf
- ¸½¼þ 18 : 9.2Clinical_Pharmacology_Biopharmaceutics_Review(s)_(PDF)__2.pdf
- ¸½¼þ 19 : 9.3Clinical_Pharmacology_Biopharmaceutics_Review(s)_(PDF)__3.pdf
- ¸½¼þ 20 : 10.1Administrative_Document(s)_&_Correspondence_(PDF)__1.pdf
- ¸½¼þ 21 : 10.2Administrative_Document(s)_&_Correspondence_(PDF)__2.pdf
- ¸½¼þ 22 : 10.3Administrative_Document(s)_&_Correspondence_(PDF)__3.pdf
- ¸½¼þ 23 : Enfuvirtide.pdf
2013-10-24 08:52:06, 153.3 K
2013-10-24 08:52:21, 563.13 K
2013-10-24 08:52:36, 161.24 K
2013-10-24 08:52:55, 262.83 K
2013-10-24 08:53:30, 1.42 M
2013-10-24 08:53:52, 1020.41 K
2013-10-24 08:53:59, 280.1 K
2013-10-24 08:54:39, 2.1 M
2013-10-24 08:55:28, 2.27 M
2013-10-24 08:56:17, 2.34 M
2013-10-24 08:56:59, 1.91 M
2013-10-24 08:57:40, 1.91 M
2013-10-24 08:58:28, 2.23 M
2013-10-24 08:59:08, 2.01 M
2013-10-24 08:59:33, 1.13 M
2013-10-24 09:00:08, 1.89 M
2013-10-24 09:00:55, 2.45 M
2013-10-24 09:01:39, 2.06 M
2013-10-24 09:02:26, 2.08 M
2013-10-24 09:03:17, 2.66 M
2013-10-24 09:04:03, 2.22 M
2013-10-24 09:04:37, 1.68 M
2013-10-24 09:04:50, 563.13 K
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