Application 021990
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 5MG BASE;160MG | Yes | No |
| 003 | EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 10MG BASE;160MG | Yes | Yes |
| 004 | EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 5MG BASE;320MG | Yes | No |
| 005 | EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 10MG BASE;320MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021990-002 | EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;160MG | TABLET / ORAL | AB | RLD | 2007-06-20 |
| N021990-003 | EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;160MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 |
| N021990-004 | EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;320MG | TABLET / ORAL | AB | RLD | 2007-06-20 |
| N021990-005 | EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;320MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021990-002 | AB |
| N021990-003 | AB |
| N021990-004 | AB |
| N021990-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021990-002 | EXFORGE | EQ 5MG BASE;160MG | TABLET / ORAL | AB | RLD | 2007-06-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021990-003 | EXFORGE | EQ 10MG BASE;160MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021990-004 | EXFORGE | EQ 5MG BASE;320MG | TABLET / ORAL | AB | RLD | 2007-06-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021990-005 | EXFORGE | EQ 10MG BASE;320MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021990-002 | EXFORGE | EQ 5MG BASE;160MG | TABLET / ORAL | AB | RLD | 2007-06-20 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021990-003 | EXFORGE | EQ 10MG BASE;160MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021990-004 | EXFORGE | EQ 5MG BASE;320MG | TABLET / ORAL | AB | RLD | 2007-06-20 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021990-005 | EXFORGE | EQ 10MG BASE;320MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021990-002 | EXFORGE | EQ 5MG BASE;160MG | TABLET / ORAL | AB | RLD | 2007-06-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021990-003 | EXFORGE | EQ 10MG BASE;160MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021990-004 | EXFORGE | EQ 5MG BASE;320MG | TABLET / ORAL | AB | RLD | 2007-06-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021990-005 | EXFORGE | EQ 10MG BASE;320MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021990-002 | EXFORGE | EQ 5MG BASE;160MG | TABLET / ORAL | AB | RLD | 2007-06-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021990-003 | EXFORGE | EQ 10MG BASE;160MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021990-004 | EXFORGE | EQ 5MG BASE;320MG | TABLET / ORAL | AB | RLD | 2007-06-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021990-005 | EXFORGE | EQ 10MG BASE;320MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021990-002 | EXFORGE | EQ 5MG BASE;160MG | TABLET / ORAL | AB | RLD | 2007-06-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021990-003 | EXFORGE | EQ 10MG BASE;160MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021990-004 | EXFORGE | EQ 5MG BASE;320MG | TABLET / ORAL | AB | RLD | 2007-06-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021990-005 | EXFORGE | EQ 10MG BASE;320MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021990-002 | EXFORGE | EQ 5MG BASE;160MG | TABLET / ORAL | AB | RLD | 2007-06-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021990-003 | EXFORGE | EQ 10MG BASE;160MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021990-004 | EXFORGE | EQ 5MG BASE;320MG | TABLET / ORAL | AB | RLD | 2007-06-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021990-005 | EXFORGE | EQ 10MG BASE;320MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021990-002 | EXFORGE | EQ 5MG BASE;160MG | TABLET / ORAL | AB | RLD | 2007-06-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021990-003 | EXFORGE | EQ 10MG BASE;160MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021990-004 | EXFORGE | EQ 5MG BASE;320MG | TABLET / ORAL | AB | RLD | 2007-06-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021990-005 | EXFORGE | EQ 10MG BASE;320MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021990-002 | EXFORGE | EQ 5MG BASE;160MG | TABLET / ORAL | AB | RLD | 2007-06-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021990-003 | EXFORGE | EQ 10MG BASE;160MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021990-004 | EXFORGE | EQ 5MG BASE;320MG | TABLET / ORAL | AB | RLD | 2007-06-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021990-005 | EXFORGE | EQ 10MG BASE;320MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021990-002 | EXFORGE | EQ 5MG BASE;160MG | TABLET / ORAL | AB | RLD | 2007-06-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021990-003 | EXFORGE | EQ 10MG BASE;160MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021990-004 | EXFORGE | EQ 5MG BASE;320MG | TABLET / ORAL | AB | RLD | 2007-06-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021990-005 | EXFORGE | EQ 10MG BASE;320MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021990-002 | EXFORGE | EQ 5MG BASE;160MG | TABLET / ORAL | AB | RLD | 2007-06-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021990-003 | EXFORGE | EQ 10MG BASE;160MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021990-004 | EXFORGE | EQ 5MG BASE;320MG | TABLET / ORAL | AB | RLD | 2007-06-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021990-005 | EXFORGE | EQ 10MG BASE;320MG | TABLET / ORAL | AB | RLD, RS | 2007-06-20 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021990-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021990-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021990-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021990-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021990-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021990-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021990-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021990-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021990-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021990-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021990-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021990-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021990-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021990-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021990-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021990-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021990-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021990-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021990-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021990-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021990-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021990-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021990-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021990-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021990-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021990-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021990-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021990-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021990-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021990-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021990-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021990-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021990-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021990-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021990-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021990-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021990-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021990-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021990-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021990-005 | AB | 1 | 5bbf6a4d5a75… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021990-002 | 6395728 | 2019-07-08 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021990-003 | 6395728 | 2019-07-08 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021990-004 | 6395728 | 2019-07-08 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021990-005 | 6395728 | 2019-07-08 | Drug product | 74a2ff9319b5… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021990-002 | 6395728 | 2019-07-08 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021990-003 | 6395728 | 2019-07-08 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021990-004 | 6395728 | 2019-07-08 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021990-005 | 6395728 | 2019-07-08 | Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021990-002 | 6395728 | 2019-07-08 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021990-003 | 6395728 | 2019-07-08 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021990-004 | 6395728 | 2019-07-08 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021990-005 | 6395728 | 2019-07-08 | Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021990-002 | 6395728 | 2019-07-08 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021990-003 | 6395728 | 2019-07-08 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021990-004 | 6395728 | 2019-07-08 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021990-005 | 6395728 | 2019-07-08 | Drug product | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Exforge | AMLODIPINE BESYLATE AND VALSARTAN | Novartis Pharmaceuticals Corporation | d0caec89-96ec-411d-a933-63eda74a6da7 | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | 021990 NDA021990 0078-0489 0078-0488 0078-0490 0078-0491 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0488 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0488 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0488 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0488 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0488 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0488 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0488 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0488 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0489 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0489 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0489 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0489 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0489 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0489 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0489 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0489 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0490 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0490 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0490 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0490 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0490 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0490 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0490 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0490 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0491 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0491 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0491 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0491 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0491 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0491 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0491 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0491 | Exforge | amlodipine besylate and valsartan | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0781-5615 | AMLODIPINE AND VALSARTAN | amlodipine besylate and valsartan | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5628 | AMLODIPINE AND VALSARTAN | amlodipine besylate and valsartan | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5639 | AMLODIPINE AND VALSARTAN | amlodipine besylate and valsartan | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-5643 | AMLODIPINE AND VALSARTAN | amlodipine besylate and valsartan | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 50090-2471 | AMLODIPINE AND VALSARTAN | amlodipine besylate and valsartan | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73304 | SUPPL | 2023-01-27 |
| 67008 | SUPPL | 2021-04-08 |
| 59064 | SUPPL | 2019-06-13 |
| 59059 | SUPPL | 2019-06-13 |
| 48427 | SUPPL | 2017-05-17 |
| 16702 | SUPPL | 2015-07-30 |
| 6606 | SUPPL | 2015-07-30 |
| 16701 | SUPPL | 2014-09-26 |
| 6605 | SUPPL | 2014-09-25 |
| 38011 | SUPPL | 2014-03-19 |
| 28992 | SUPPL | 2014-03-19 |
| 6604 | SUPPL | 2014-03-19 |
| 16700 | SUPPL | 2012-12-10 |
| 28991 | SUPPL | 2012-11-29 |
| 28990 | SUPPL | 2012-10-02 |
| 38010 | SUPPL | 2012-10-01 |
| 38009 | SUPPL | 2012-01-30 |
| 6603 | SUPPL | 2012-01-20 |
| 28989 | SUPPL | 2011-12-14 |
| 16699 | SUPPL | 2011-12-13 |
| 6602 | SUPPL | 2011-11-02 |
| 38008 | SUPPL | 2011-10-31 |
| 16698 | SUPPL | 2011-06-07 |
| 28988 | SUPPL | 2011-06-03 |
| 6601 | SUPPL | 2010-04-05 |
| 38007 | SUPPL | 2010-04-04 |
| 42370 | ORIG | 2008-10-03 |
| 6600 | SUPPL | 2008-07-25 |
| 38006 | SUPPL | 2008-07-24 |
| 6599 | ORIG | 2007-07-05 |
| 38005 | ORIG | 2007-06-25 |
| 6598 | ORIG | 2007-01-08 |