Application 206083
- Type
- ANDA
- Sponsor
- PRINSTON INC
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 |
|---|---|---|---|---|---|---|---|
| A206083-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;80MG | TABLET / ORAL | AB | 2016-02-08 | |
| A206083-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;160MG | TABLET / ORAL | AB | 2016-02-08 | |
| A206083-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;320MG | TABLET / ORAL | AB | 2016-02-08 | |
| A206083-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;160MG | TABLET / ORAL | AB | 2016-02-08 | |
| A206083-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;320MG | TABLET / ORAL | AB | 2016-02-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206083-001 | AB |
| A206083-002 | AB |
| A206083-003 | AB |
| A206083-004 | AB |
| A206083-005 | 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 | A206083-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2016-02-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206083-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2016-02-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206083-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2016-02-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206083-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2016-02-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206083-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2016-02-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A206083-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2016-02-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206083-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2016-02-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206083-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2016-02-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206083-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2016-02-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206083-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2016-02-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206083-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2016-02-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206083-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2016-02-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206083-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2016-02-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206083-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2016-02-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206083-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2016-02-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206083-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2016-02-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206083-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2016-02-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206083-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2016-02-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206083-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2016-02-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206083-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2016-02-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206083-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2016-02-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206083-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2016-02-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206083-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2016-02-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206083-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2016-02-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206083-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2016-02-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206083-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2016-02-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206083-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2016-02-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206083-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2016-02-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206083-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2016-02-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206083-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2016-02-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206083-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2016-02-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206083-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2016-02-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206083-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2016-02-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206083-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2016-02-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206083-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2016-02-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206083-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2016-02-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206083-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2016-02-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206083-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2016-02-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206083-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2016-02-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206083-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2016-02-08 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206083-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206083-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206083-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206083-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206083-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206083-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206083-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206083-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206083-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206083-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206083-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206083-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206083-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206083-004 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206083-005 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A206083-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206083-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206083-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206083-004 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206083-005 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206083-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206083-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206083-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206083-004 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206083-005 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206083-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206083-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206083-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206083-004 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206083-005 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206083-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206083-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206083-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206083-004 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206083-005 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A206083-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A206083-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A206083-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A206083-004 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A206083-005 | AB | 1 | 8072bd15b7f6… |
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 | af46984c-cb58-4886-baa2-0ee075242c27 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | 206083 ANDA206083 |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | Preferred Pharmaceuticals Inc. | d09747f0-029e-4090-949b-e939948249b5 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 206083 ANDA206083 |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | Solco Healthcare US, LLC | f8b0a8ab-4549-4553-a127-bf2c0291a4b1 | 2025-07-31 | Boxed warning, Warnings, Adverse reactions | 206083 ANDA206083 43547-314 43547-312 43547-313 43547-311 43547-315 |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | f1df0d1e-d418-4f6e-a04a-77b5d4000e2b | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | 206083 ANDA206083 |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | d55b2f01-5cd1-40bb-8d36-34b5b9081ddc | 2025-05-29 | Boxed warning, Warnings, Adverse reactions | 206083 ANDA206083 |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 46addda8-f798-4207-b8fb-ea75c5903a36 | 2025-05-29 | Boxed warning, Warnings, Adverse reactions | 206083 ANDA206083 |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 3f1321b2-cad7-47c7-863f-38aa7a8b3599 | 2024-11-08 | Boxed warning, Warnings, Adverse reactions | 206083 ANDA206083 |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 93833cf2-631b-4058-809d-16cc11b858c0 | 2024-11-08 | Boxed warning, Warnings, Adverse reactions | 206083 ANDA206083 |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | b6dc0544-898e-41e3-bd18-5757ede4477d | 2024-11-08 | Boxed warning, Warnings, Adverse reactions | 206083 ANDA206083 |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 38d84a2b-3c83-44a0-97d8-3f64d6101732 | 2023-11-21 | Boxed warning, Warnings, Adverse reactions | 206083 ANDA206083 71335-2200 |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | VALSARTAN AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 3131809e-885a-42d3-b6ad-1b208fd3ba56 | 2023-10-31 | Boxed warning, Warnings, Adverse reactions | 206083 ANDA206083 50090-6232 |
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 |
|---|---|---|---|---|---|
| 43547-311 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-311 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-311 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-311 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-311 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-312 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-312 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-312 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-312 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-312 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-313 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-313 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-313 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-313 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-313 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-314 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-314 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-314 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-314 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-314 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-315 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-315 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-315 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-315 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 43547-315 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Solco Healthcare US, LLC | ANDA | Current |
| 50090-6232 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 68071-4183 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 70518-0607 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | REMEDYREPACK INC. | ANDA | Current |
| 70518-0925 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | REMEDYREPACK INC. | ANDA | Current |
| 71335-2200 | VALSARTAN AND HYDROCHLOROTHIAZIDE | valsartan and hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |