Application 019787
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORVASC | AMLODIPINE BESYLATE | TABLET;ORAL | EQ 2.5MG BASE | Yes | No |
| 002 | NORVASC | AMLODIPINE BESYLATE | TABLET;ORAL | EQ 5MG BASE | Yes | No |
| 003 | NORVASC | AMLODIPINE BESYLATE | TABLET;ORAL | EQ 10MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019787-001 | NORVASC | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 |
| N019787-002 | NORVASC | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 |
| N019787-003 | NORVASC | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-07-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019787-001 | AB |
| N019787-002 | AB |
| N019787-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N019787-001 | NORVASC | EQ 2.5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019787-002 | NORVASC | EQ 5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019787-003 | NORVASC | EQ 10MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-07-31 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019787-001 | NORVASC | EQ 2.5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019787-002 | NORVASC | EQ 5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019787-003 | NORVASC | EQ 10MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-07-31 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019787-001 | NORVASC | EQ 2.5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019787-002 | NORVASC | EQ 5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019787-003 | NORVASC | EQ 10MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-07-31 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019787-001 | NORVASC | EQ 2.5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019787-002 | NORVASC | EQ 5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019787-003 | NORVASC | EQ 10MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-07-31 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019787-001 | NORVASC | EQ 2.5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019787-002 | NORVASC | EQ 5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019787-003 | NORVASC | EQ 10MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-07-31 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019787-001 | NORVASC | EQ 2.5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019787-002 | NORVASC | EQ 5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019787-003 | NORVASC | EQ 10MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-07-31 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019787-001 | NORVASC | EQ 2.5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019787-002 | NORVASC | EQ 5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019787-003 | NORVASC | EQ 10MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-07-31 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019787-001 | NORVASC | EQ 2.5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019787-002 | NORVASC | EQ 5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019787-003 | NORVASC | EQ 10MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-07-31 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019787-001 | NORVASC | EQ 2.5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019787-002 | NORVASC | EQ 5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019787-003 | NORVASC | EQ 10MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-07-31 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019787-001 | NORVASC | EQ 2.5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019787-002 | NORVASC | EQ 5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019787-003 | NORVASC | EQ 10MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-07-31 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019787-001 | NORVASC | EQ 2.5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019787-002 | NORVASC | EQ 5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019787-003 | NORVASC | EQ 10MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-07-31 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019787-001 | NORVASC | EQ 2.5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019787-002 | NORVASC | EQ 5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019787-003 | NORVASC | EQ 10MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-07-31 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019787-001 | NORVASC | EQ 2.5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019787-002 | NORVASC | EQ 5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019787-003 | NORVASC | EQ 10MG BASE | TABLET / ORAL | AB | RLD, RS | 1992-07-31 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019787-001 | NORVASC | EQ 2.5MG BASE | TABLET / ORAL | AB | RLD | 1992-07-31 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N019787-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019787-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019787-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019787-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019787-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019787-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019787-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019787-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019787-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019787-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019787-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019787-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019787-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019787-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019787-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019787-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019787-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019787-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019787-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019787-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019787-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019787-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019787-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019787-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019787-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019787-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019787-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019787-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019787-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019787-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N019787-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019787-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N019787-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019787-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019787-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019787-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019787-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019787-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019787-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019787-001 | AB | 1 | 1e350fbaab3a… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| amlodipine besylate | AMLODIPINE BESYLATE | Mylan Pharmaceuticals Inc. | 180ee374-24f2-4b9c-9d54-8815f2b1dc9b | 2024-11-28 | Warnings, Adverse reactions | 019787 NDA019787 59762-2135 59762-2010 59762-2242 |
| Norvasc | AMLODIPINE BESYLATE | Viatris Specialty LLC | 7367289c-b0b0-466a-83e2-558e2985c29f | 2023-02-15 | Warnings, Adverse reactions | 019787 NDA019787 |
| amlodipine besylate | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | f3482709-c5c3-4bd0-8067-ad57f31bb525 | 2022-10-18 | Warnings, Adverse reactions | 019787 NDA019787 71610-469 |
| Norvasc | AMLODIPINE BESYLATE | PFIZER LABORATORIES DIV PFIZER INC | abd6a2ca-40c2-485c-bc53-db1c652505ed | 2019-01-15 | Warnings, Adverse reactions | 019787 NDA019787 0069-1540 0069-1520 0069-1530 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-1520 | Norvasc | amlodipine besylate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1520 | Norvasc | amlodipine besylate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1530 | Norvasc | amlodipine besylate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1530 | Norvasc | amlodipine besylate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1540 | Norvasc | amlodipine besylate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-1540 | Norvasc | amlodipine besylate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 21695-151 | Norvasc | amlodipine besylate | Rebel Distributors Corp | NDA | Current |
| 55154-0535 | amlodipine besylate | amlodipine besylate | Cardinal Health | NDA | Current |
| 55289-103 | Norvasc | amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-103 | Norvasc | amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-103 | Norvasc | amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-103 | Norvasc | amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-103 | Norvasc | amlodipine besylate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 59762-1520 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1520 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1520 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1520 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1530 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1530 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1530 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1530 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1540 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1540 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1540 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-1540 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2010 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2010 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2010 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2010 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2010 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2135 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2135 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2135 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2135 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2135 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2242 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2242 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2242 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2242 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2242 | amlodipine besylate | amlodipine besylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 67046-020 | amlodipine besylate | amlodipine besylate | Contract Pharmacy Services-PA | NDA AUTHORIZED GENERIC | Current |
| 67296-0672 | amlodipine besylate | amlodipine besylate | RedPharm Drug Inc. | NDA AUTHORIZED GENERIC | Current |
| 67296-0673 | amlodipine besylate | amlodipine besylate | RedPharm Drug Inc. | NDA AUTHORIZED GENERIC | Current |
| 69189-1540 | amlodipine besylate | amlodipine besylate | Avera McKennan Hospital | NDA AUTHORIZED GENERIC | Current |
| 71610-469 | amlodipine besylate | amlodipine besylate | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 71610-469 | amlodipine besylate | amlodipine besylate | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 50438 | SUPPL | 2017-11-17 |
| 50296 | SUPPL | 2017-11-06 |
| 47825 | SUPPL | 2017-04-03 |
| 47800 | SUPPL | 2017-03-31 |
| 11721 | SUPPL | 2015-04-09 |
| 19224 | SUPPL | 2015-03-25 |
| 19223 | SUPPL | 2013-01-08 |
| 19222 | SUPPL | 2013-01-08 |
| 11720 | SUPPL | 2013-01-07 |
| 11719 | SUPPL | 2013-01-07 |
| 19221 | SUPPL | 2011-11-02 |
| 11718 | SUPPL | 2011-10-31 |
| 1623 | SUPPL | 2011-05-11 |
| 33954 | SUPPL | 2011-05-09 |
| 33953 | SUPPL | 2010-02-23 |
| 19220 | SUPPL | 2010-02-22 |
| 1622 | SUPPL | 2007-11-08 |
| 11717 | SUPPL | 2007-11-07 |
| 41035 | SUPPL | 2007-03-02 |
| 19219 | SUPPL | 2005-10-20 |
| 33952 | SUPPL | 2005-09-30 |
| 33951 | SUPPL | 2005-07-15 |
| 1621 | SUPPL | 2005-07-15 |
| 1617 | SUPPL | 2004-06-10 |
| 1619 | SUPPL | 2004-01-09 |
| 19217 | SUPPL | 2003-12-08 |
| 1620 | SUPPL | 2003-08-28 |
| 41032 | SUPPL | 2003-08-05 |
| 41031 | SUPPL | 2003-08-05 |
| 41030 | SUPPL | 2003-08-05 |
| 41029 | SUPPL | 2003-08-05 |
| 41028 | SUPPL | 2003-08-05 |
| 41026 | SUPPL | 2003-08-05 |
| 41025 | SUPPL | 2003-08-05 |
| 41024 | SUPPL | 2003-08-05 |
| 20358 | SUPPL | 2003-08-05 |
| 20356 | SUPPL | 2003-08-05 |
| 20354 | SUPPL | 2003-08-05 |
| 20353 | SUPPL | 2003-08-05 |
| 20352 | SUPPL | 2003-08-05 |
| 20351 | SUPPL | 2003-08-05 |
| 19218 | SUPPL | 2002-05-28 |
| 41027 | SUPPL | 2002-04-30 |
| 41034 | SUPPL | 2000-07-12 |
| 20357 | SUPPL | 2000-07-12 |
| 1618 | SUPPL | 2000-07-12 |
| 1616 | SUPPL | 2000-07-12 |
| 20359 | SUPPL | 2000-02-01 |
| 20360 | SUPPL | 1999-12-15 |
| 41033 | SUPPL | 1999-06-04 |
| 20355 | SUPPL | 1997-01-08 |