Application 201662
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 12.5MG;80MG | No | No |
| 002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 12.5MG;160MG | No | No |
| 003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 12.5MG;320MG | No | No |
| 004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 25MG;160MG | No | No |
| 005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 25MG;320MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201662-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;80MG | TABLET / ORAL | AB | 2013-03-21 | |
| A201662-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;160MG | TABLET / ORAL | AB | 2013-03-21 | |
| A201662-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;320MG | TABLET / ORAL | AB | 2013-03-21 | |
| A201662-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;160MG | TABLET / ORAL | AB | 2013-03-21 | |
| A201662-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;320MG | TABLET / ORAL | AB | 2013-03-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A201662-001 | AB |
| A201662-002 | AB |
| A201662-003 | AB |
| A201662-004 | AB |
| A201662-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A201662-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201662-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201662-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201662-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201662-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201662-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-03-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201662-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201662-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201662-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201662-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201662-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201662-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201662-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201662-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201662-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201662-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-03-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201662-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-03-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201662-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-03-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201662-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-03-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201662-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-03-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201662-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-03-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201662-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-03-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201662-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-03-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201662-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-03-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201662-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-03-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201662-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-03-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201662-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201662-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201662-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201662-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201662-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-03-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201662-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201662-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201662-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201662-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201662-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-03-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201662-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201662-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201662-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201662-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A201662-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201662-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201662-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201662-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201662-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201662-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201662-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201662-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201662-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201662-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A201662-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201662-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201662-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201662-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201662-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201662-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201662-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201662-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201662-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201662-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201662-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201662-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201662-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201662-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201662-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201662-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201662-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201662-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201662-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201662-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201662-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201662-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201662-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201662-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201662-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201662-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201662-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201662-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201662-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201662-005 | AB | 1 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 09c55798-5313-4250-8d8f-9c5644e8c1b0 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | 201662 ANDA201662 50090-3485 50090-3292 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | d57188d2-c3af-4879-bf17-f37eaf733aca | 2024-07-09 | Boxed warning, Warnings, Adverse reactions | 201662 ANDA201662 71335-0853 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Alembic Pharmaceuticals Inc. | 973973a3-9fec-4afc-910f-187f099dfe2d | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | 201662 ANDA201662 62332-081 62332-080 62332-082 62332-079 62332-083 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | f1ef2a2c-7b8d-4127-8f47-29e430fba70b | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | 201662 ANDA201662 50090-4872 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Alembic Pharmaceuticals Limited | 3b80f726-9e1e-4d44-ad4f-afd10e26292f | 2023-01-27 | Boxed warning, Warnings, Adverse reactions | 201662 ANDA201662 46708-456 46708-453 46708-455 46708-454 46708-457 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | a06ee3c1-bd0d-4dda-a453-1655eebffdae | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 201662 ANDA201662 63187-943 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | ec24af8d-29a3-4217-8f06-ac217ea55b9e | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 201662 ANDA201662 71205-042 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | 6c363351-6596-42bf-83c9-041bf231b778 | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 201662 ANDA201662 71205-015 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 46708-453 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-453 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-454 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-454 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-455 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-455 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-456 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-456 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-457 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-457 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Limited | ANDA | Current |
| 50090-3292 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-3485 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-3485 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-3485 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-3485 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-4839 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-4839 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-4872 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-4872 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-4883 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-4883 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 62332-079 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-079 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-079 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-079 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals I | ANDA | Current |
| 62332-079 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-080 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-080 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-080 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-080 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals I | ANDA | Current |
| 62332-080 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-081 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-081 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-081 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-081 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals I | ANDA | Current |
| 62332-081 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-082 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-082 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-082 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-082 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals I | ANDA | Current |
| 62332-082 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-083 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-083 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-083 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-083 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals I | ANDA | Current |
| 62332-083 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 63187-943 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 63187-943 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 68071-4333 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4333 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4376 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4376 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71205-015 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 71205-015 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 71205-042 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 71205-042 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 71335-0853 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 71335-0853 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 71335-0853 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |