Application 074896
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 25MG;15MG | No | No |
| 002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 25MG;25MG | No | Yes |
| 003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 50MG;25MG | No | No |
| 004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 50MG;15MG | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074896-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | ||
| A074896-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | RS | 1997-12-29 | |
| A074896-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | ||
| A074896-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | RS | 1997-12-29 |
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 | A074896-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A074896-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | RS | 1997-12-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A074896-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A074896-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | RS | 1997-12-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A074896-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074896-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | RS | 1997-12-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A074896-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074896-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | RS | 1997-12-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074896-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074896-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | RS | 1997-12-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074896-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074896-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | RS | 1997-12-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074896-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074896-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | RS | 1997-12-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074896-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074896-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | RS | 1997-12-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074896-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074896-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | RS | 1997-12-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074896-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074896-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | RS | 1997-12-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074896-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074896-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | RS | 1997-12-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074896-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074896-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | RS | 1997-12-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074896-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074896-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | RS | 1997-12-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074896-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074896-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | RS | 1997-12-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074896-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074896-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | RS | 1997-12-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074896-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074896-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | RS | 1997-12-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074896-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074896-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | RS | 1997-12-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074896-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074896-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | RS | 1997-12-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074896-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074896-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | RS | 1997-12-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074896-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074896-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | RS | 1997-12-29 | 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 |
|---|---|---|---|---|---|---|
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | Rising Pharma Holdings, Inc. | 0ea90fd4-0da6-4ad2-ab83-6cfbe0ae515e | 2023-02-21 | Boxed warning, Warnings, Adverse reactions | 074896 ANDA074896 |
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 |
|---|---|---|---|---|---|
| 0378-0081 | Captopril and Hydrochlorothiazide | captopril and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0081 | Captopril and Hydrochlorothiazide | captopril and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0083 | Captopril and Hydrochlorothiazide | captopril and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0083 | Captopril and Hydrochlorothiazide | captopril and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0084 | Captopril and Hydrochlorothiazide | captopril and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0084 | Captopril and Hydrochlorothiazide | captopril and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0086 | Captopril and Hydrochlorothiazide | captopril and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0086 | Captopril and Hydrochlorothiazide | captopril and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |