Application 091519
- Type
- ANDA
- Sponsor
- WATSON LABS TEVA
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 |
|---|---|---|---|---|---|---|---|
| A091519-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;80MG | TABLET / ORAL | 2013-03-21 | ||
| A091519-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;160MG | TABLET / ORAL | 2013-03-21 | ||
| A091519-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;320MG | TABLET / ORAL | 2013-03-21 | ||
| A091519-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;160MG | TABLET / ORAL | 2013-03-21 | ||
| A091519-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;320MG | 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 | A091519-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2013-03-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091519-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | 2013-03-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091519-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | 2013-03-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091519-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | 2013-03-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091519-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | 2013-03-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091519-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2013-03-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091519-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | 2013-03-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091519-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | 2013-03-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091519-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | 2013-03-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091519-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | 2013-03-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091519-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2013-03-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091519-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | 2013-03-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091519-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | 2013-03-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091519-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | 2013-03-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091519-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | 2013-03-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091519-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2013-03-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091519-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | 2013-03-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091519-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | 2013-03-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091519-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | 2013-03-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091519-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | 2013-03-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091519-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2013-03-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091519-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | 2013-03-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091519-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | 2013-03-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091519-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | 2013-03-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091519-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | 2013-03-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091519-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2013-03-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091519-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | 2013-03-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091519-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | 2013-03-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091519-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | 2013-03-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091519-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | 2013-03-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091519-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2013-03-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091519-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | 2013-03-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091519-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | 2013-03-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091519-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | 2013-03-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091519-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | 2013-03-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091519-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2013-03-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091519-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | 2013-03-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091519-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | 2013-03-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091519-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | 2013-03-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091519-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | 2013-03-21 | 03ed91905a0d… |
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 | Bryant Ranch Prepack | 167f49f0-2d39-49a2-9f9e-1359a7c7ba3d | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | Valsartan and Hydrochlorothiazide |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | ScieGen Pharmaceuticals, INC. | 17362ff8-07bb-42c6-a100-8adb93be0348 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | VALSARTAN AND HYDROCHLOROTHIAZIDE |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | 191d5710-7b8a-0b61-e063-6394a90afd41 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | Valsartan and Hydrochlorothiazide |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | af46984c-cb58-4886-baa2-0ee075242c27 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | VALSARTAN AND HYDROCHLOROTHIAZIDE |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | AvKARE | 05ba1369-6484-75d4-e063-6294a90a63e4 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | Valsartan and Hydrochlorothiazide |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 09c55798-5313-4250-8d8f-9c5644e8c1b0 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | Valsartan and Hydrochlorothiazide |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | f2b749a6-17ff-e044-e053-2995a90aea28 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Valsartan and Hydrochlorothiazide |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | f835fa93-6529-c06d-e053-6394a90ad42a | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Valsartan and Hydrochlorothiazide |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | db118092-2002-7a55-e053-2a95a90a7b2c | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Valsartan and Hydrochlorothiazide |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | db4d84ce-cf51-61dc-e053-2a95a90a2cfd | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Valsartan and Hydrochlorothiazide |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | Preferred Pharmaceuticals Inc. | d09747f0-029e-4090-949b-e939948249b5 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | VALSARTAN AND HYDROCHLOROTHIAZIDE |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | Solco Healthcare US, LLC | f8b0a8ab-4549-4553-a127-bf2c0291a4b1 | 2025-07-31 | Boxed warning, Warnings, Adverse reactions | VALSARTAN AND HYDROCHLOROTHIAZIDE |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | f1df0d1e-d418-4f6e-a04a-77b5d4000e2b | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | VALSARTAN AND HYDROCHLOROTHIAZIDE |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | d55b2f01-5cd1-40bb-8d36-34b5b9081ddc | 2025-05-29 | Boxed warning, Warnings, Adverse reactions | VALSARTAN AND HYDROCHLOROTHIAZIDE |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 46addda8-f798-4207-b8fb-ea75c5903a36 | 2025-05-29 | Boxed warning, Warnings, Adverse reactions | VALSARTAN AND HYDROCHLOROTHIAZIDE |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 3f1321b2-cad7-47c7-863f-38aa7a8b3599 | 2024-11-08 | Boxed warning, Warnings, Adverse reactions | VALSARTAN AND HYDROCHLOROTHIAZIDE |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 93833cf2-631b-4058-809d-16cc11b858c0 | 2024-11-08 | Boxed warning, Warnings, Adverse reactions | VALSARTAN AND HYDROCHLOROTHIAZIDE |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | b6dc0544-898e-41e3-bd18-5757ede4477d | 2024-11-08 | Boxed warning, Warnings, Adverse reactions | VALSARTAN AND HYDROCHLOROTHIAZIDE |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | d57188d2-c3af-4879-bf17-f37eaf733aca | 2024-07-09 | Boxed warning, Warnings, Adverse reactions | Valsartan and Hydrochlorothiazide |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Aurobindo Pharma Limited | c5bc7c55-b50c-4e61-ad1f-5ebb607c262f | 2024-06-15 | Boxed warning, Warnings, Adverse reactions | Valsartan and Hydrochlorothiazide |
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 |
|---|---|---|---|---|---|
| 0591-2315 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2316 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2317 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2318 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2319 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Actavis Pharma, Inc. | ANDA | Current |
| 42291-884 | Valsartan and hydrochlorothiazide | Valsartan and hydrochlorothiazide | AvKARE, Inc. | ANDA | Current |
| 42291-884 | Valsartan and hydrochlorothiazide | Valsartan and hydrochlorothiazide | AvKARE, Inc. | ANDA | Current |
| 42291-885 | Valsartan and hydrochlorothiazide | Valsartan and hydrochlorothiazide | AvKARE, Inc. | ANDA | Current |
| 42291-886 | Valsartan and hydrochlorothiazide | Valsartan and hydrochlorothiazide | AvKARE, Inc. | ANDA | Current |
| 42291-886 | Valsartan and hydrochlorothiazide | Valsartan and hydrochlorothiazide | AvKARE, Inc. | ANDA | Current |
| 42291-887 | Valsartan and hydrochlorothiazide | Valsartan and hydrochlorothiazide | AvKARE, Inc. | ANDA | Current |
| 42291-887 | Valsartan and hydrochlorothiazide | Valsartan and hydrochlorothiazide | AvKARE, Inc. | ANDA | Current |
| 42291-888 | Valsartan and hydrochlorothiazide | Valsartan and hydrochlorothiazide | AvKARE, Inc. | ANDA | Current |
| 42291-888 | Valsartan and hydrochlorothiazide | Valsartan and hydrochlorothiazide | AvKARE, Inc. | ANDA | Current |
| 50090-2640 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 51655-950 | Valsartan HCTZ | Valsartan HCTZ | Northwind Pharmaceuticals | ANDA | Current |
| 61919-634 | VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | DirectRX | ANDA | Current |
| 63187-428 | Valsartan and hydrochlorothiazide | Valsartan and hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 63187-428 | Valsartan and hydrochlorothiazide | Valsartan and hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 68071-2119 | Valsartan and hydrochlorothiazide | Valsartan and hydrochlorothiazide | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4311 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71205-004 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |
| 71205-004 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Proficient Rx LP | ANDA | Current |