Application 074827
- Type
- ANDA
- Sponsor
- ACP NIMBLE
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 | No |
| 003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 50MG;25MG | No | No |
| 004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 50MG;15MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074827-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | ||
| A074827-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | 1997-12-29 | ||
| A074827-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | ||
| A074827-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074827-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074827-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | 1997-12-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074827-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074827-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | 1997-12-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074827-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074827-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | 1997-12-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074827-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074827-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | 1997-12-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074827-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074827-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | 1997-12-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074827-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074827-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | 1997-12-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074827-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074827-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | 1997-12-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074827-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074827-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | 1997-12-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074827-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074827-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | 1997-12-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074827-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074827-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | 1997-12-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074827-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074827-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | 1997-12-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074827-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074827-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | 1997-12-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074827-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074827-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | 1997-12-29 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074827-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074827-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | 1997-12-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074827-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074827-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | 1997-12-29 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074827-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074827-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | 1997-12-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074827-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074827-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | 1997-12-29 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074827-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074827-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | 1997-12-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074827-001 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;15MG | TABLET / ORAL | 1997-12-29 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074827-002 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;25MG | TABLET / ORAL | 1997-12-29 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074827-003 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;25MG | TABLET / ORAL | 1997-12-29 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074827-004 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE | 50MG;15MG | TABLET / ORAL | 1997-12-29 | 4b0b4de00fa7… |
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 | CAPTOPRIL AND HYDROCHLOROTHIAZIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.