Application 078946
- Type
- ANDA
- Sponsor
- LUPIN LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 12.5MG;320MG | No | No |
| 002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 25MG;320MG | No | No |
| 003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 12.5MG;80MG | No | No |
| 004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 12.5MG;160MG | No | No |
| 005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET;ORAL | 25MG;160MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078946-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;320MG | TABLET / ORAL | 2013-03-21 | ||
| A078946-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;320MG | TABLET / ORAL | 2013-03-21 | ||
| A078946-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;80MG | TABLET / ORAL | 2013-03-21 | ||
| A078946-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;160MG | TABLET / ORAL | 2013-03-21 | ||
| A078946-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;160MG | TABLET / ORAL | 2013-03-21 |
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 | A078946-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | 2013-03-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078946-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | 2013-03-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078946-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2013-03-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078946-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | 2013-03-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078946-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | 2013-03-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078946-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | 2013-03-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078946-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | 2013-03-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078946-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2013-03-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078946-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | 2013-03-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078946-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | 2013-03-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078946-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078946-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078946-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078946-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078946-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078946-001 | 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 | A078946-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078946-003 | 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 | A078946-004 | 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 | A078946-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078946-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078946-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078946-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078946-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078946-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078946-001 | 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 | A078946-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-03-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078946-003 | 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 | A078946-004 | 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 | A078946-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-03-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078946-001 | 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 | A078946-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-03-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078946-003 | 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 | A078946-004 | 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 | A078946-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-03-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078946-001 | 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 | A078946-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-03-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078946-003 | 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 | A078946-004 | 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 | A078946-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-03-21 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078946-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078946-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078946-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078946-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078946-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078946-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078946-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078946-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078946-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078946-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078946-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078946-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078946-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078946-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078946-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078946-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078946-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078946-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078946-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078946-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078946-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078946-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078946-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078946-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078946-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078946-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078946-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078946-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078946-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078946-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078946-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078946-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078946-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078946-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078946-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078946-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078946-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078946-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078946-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078946-005 | 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 | Lupin Pharmaceuticals, Inc. | d74a85de-5917-401a-b92d-6a95da5d30a6 | 2023-11-30 | Boxed warning, Warnings, Adverse reactions | 078946 ANDA078946 68180-104 68180-102 68180-103 68180-105 68180-101 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | be008c6a-6036-4abf-a3fc-450465c88d55 | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 078946 ANDA078946 71205-249 |
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 |
|---|---|---|---|---|---|
| 35356-976 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50268-790 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | AvPAK | ANDA | Current |
| 50268-791 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | AvPAK | ANDA | Current |
| 50268-792 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | AvPAK | ANDA | Current |
| 50268-793 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | AvPAK | ANDA | Current |
| 50268-794 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | AvPAK | ANDA | Current |
| 53002-1784 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1785 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1787 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1788 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-014 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-023 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 57297-101 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | LUPIN LIMITED | ANDA | Current |
| 57297-102 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | LUPIN LIMITED | ANDA | Current |
| 57297-103 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | LUPIN LIMITED | ANDA | Current |
| 57297-104 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | LUPIN LIMITED | ANDA | Current |
| 57297-105 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | LUPIN LIMITED | ANDA | Current |
| 68180-101 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-101 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-101 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-102 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-102 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-102 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-103 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-103 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-103 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-104 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-104 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-104 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-105 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-105 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-105 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68258-6969 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Dispensing Solutions, Inc. | ANDA | Current |
| 71205-249 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 71205-249 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |