Application 203145
- Type
- ANDA
- Sponsor
- MACLEODS 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 |
|---|---|---|---|---|---|---|---|
| A203145-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;80MG | TABLET / ORAL | AB | 2013-04-19 | |
| A203145-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;160MG | TABLET / ORAL | AB | 2013-04-19 | |
| A203145-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;320MG | TABLET / ORAL | AB | 2013-04-19 | |
| A203145-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;160MG | TABLET / ORAL | AB | 2013-04-19 | |
| A203145-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;320MG | TABLET / ORAL | AB | 2013-04-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203145-001 | AB |
| A203145-002 | AB |
| A203145-003 | AB |
| A203145-004 | AB |
| A203145-005 | 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 | A203145-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-04-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203145-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-04-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203145-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-04-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203145-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-04-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203145-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-04-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A203145-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-04-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203145-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-04-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203145-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-04-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203145-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-04-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203145-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-04-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203145-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-04-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203145-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-04-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203145-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-04-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203145-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-04-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203145-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-04-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203145-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-04-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203145-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-04-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203145-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-04-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203145-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-04-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203145-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-04-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203145-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-04-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203145-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-04-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203145-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-04-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203145-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-04-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203145-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-04-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203145-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-04-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203145-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-04-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203145-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-04-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203145-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-04-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203145-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-04-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203145-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-04-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203145-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-04-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203145-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-04-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203145-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-04-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203145-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-04-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203145-001 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | AB | 2013-04-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203145-002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;160MG | TABLET / ORAL | AB | 2013-04-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203145-003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;320MG | TABLET / ORAL | AB | 2013-04-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203145-004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;160MG | TABLET / ORAL | AB | 2013-04-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203145-005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | 25MG;320MG | TABLET / ORAL | AB | 2013-04-19 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A203145-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203145-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203145-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203145-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203145-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A203145-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203145-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203145-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203145-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203145-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203145-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203145-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203145-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203145-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203145-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203145-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203145-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203145-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203145-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203145-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203145-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203145-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203145-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203145-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203145-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203145-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203145-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203145-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203145-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203145-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203145-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203145-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203145-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203145-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203145-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203145-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203145-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203145-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203145-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203145-005 | AB | 1 | 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 | 203145 ANDA203145 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | 191d5710-7b8a-0b61-e063-6394a90afd41 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | 203145 ANDA203145 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | db118092-2002-7a55-e053-2a95a90a7b2c | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 203145 ANDA203145 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | db4d84ce-cf51-61dc-e053-2a95a90a2cfd | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 203145 ANDA203145 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | ddc8b9e7-ceb1-4b6c-aa98-1c2cb98b0fc8 | 2024-02-12 | Boxed warning, Warnings, Adverse reactions | 203145 ANDA203145 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 7b3fbdc9-d7e0-498f-a52d-e8a6b34f4a1f | 2024-01-30 | Boxed warning, Warnings, Adverse reactions | 203145 ANDA203145 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 497223a9-0d53-4f79-b031-07cc5204d80f | 2023-11-21 | Boxed warning, Warnings, Adverse reactions | 203145 ANDA203145 71335-0547 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 89ce2fb1-330c-45f9-bd37-b402feea9378 | 2023-10-31 | Boxed warning, Warnings, Adverse reactions | 203145 ANDA203145 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | ef100fa1-dd63-4287-8543-480a82ace168 | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | 203145 ANDA203145 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Macleods Pharmaceuticals Limited | 771afba6-8769-4ea8-afec-358dba0aaefe | 2022-11-02 | Boxed warning, Warnings, Adverse reactions | 203145 ANDA203145 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | a9098fc6-3d2a-404f-a4cd-2e181ebbd626 | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | 203145 ANDA203145 |
| Valsartan and Hydrochlorothiazide | VALSARTAN AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | e0349fe8-90a4-4236-9686-f0c9c00a001c | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 203145 ANDA203145 |
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 |
|---|---|---|---|---|---|
| 71335-0227 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 71335-0547 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 71610-327 | Valsartan and Hydrochlorothiazide | Valsartan and Hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |