Application 074423
- Type
- ANDA
- Sponsor
- DAVA PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CAPTOPRIL | CAPTOPRIL | TABLET;ORAL | 12.5MG | No | No |
| 002 | CAPTOPRIL | CAPTOPRIL | TABLET;ORAL | 25MG | No | No |
| 003 | CAPTOPRIL | CAPTOPRIL | TABLET;ORAL | 50MG | No | No |
| 004 | CAPTOPRIL | CAPTOPRIL | TABLET;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074423-001 | CAPTOPRIL | CAPTOPRIL | 12.5MG | TABLET / ORAL | 1996-02-13 | ||
| A074423-002 | CAPTOPRIL | CAPTOPRIL | 25MG | TABLET / ORAL | 1996-02-13 | ||
| A074423-003 | CAPTOPRIL | CAPTOPRIL | 50MG | TABLET / ORAL | 1996-02-13 | ||
| A074423-004 | CAPTOPRIL | CAPTOPRIL | 100MG | TABLET / ORAL | 1996-02-13 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A074423-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | 1996-02-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074423-002 | CAPTOPRIL | 25MG | TABLET / ORAL | 1996-02-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074423-003 | CAPTOPRIL | 50MG | TABLET / ORAL | 1996-02-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074423-004 | CAPTOPRIL | 100MG | TABLET / ORAL | 1996-02-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074423-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | 1996-02-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074423-002 | CAPTOPRIL | 25MG | TABLET / ORAL | 1996-02-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074423-003 | CAPTOPRIL | 50MG | TABLET / ORAL | 1996-02-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074423-004 | CAPTOPRIL | 100MG | TABLET / ORAL | 1996-02-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074423-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | 1996-02-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074423-002 | CAPTOPRIL | 25MG | TABLET / ORAL | 1996-02-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074423-003 | CAPTOPRIL | 50MG | TABLET / ORAL | 1996-02-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074423-004 | CAPTOPRIL | 100MG | TABLET / ORAL | 1996-02-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074423-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | 1996-02-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074423-002 | CAPTOPRIL | 25MG | TABLET / ORAL | 1996-02-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074423-003 | CAPTOPRIL | 50MG | TABLET / ORAL | 1996-02-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074423-004 | CAPTOPRIL | 100MG | TABLET / ORAL | 1996-02-13 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074423-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | 1996-02-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074423-002 | CAPTOPRIL | 25MG | TABLET / ORAL | 1996-02-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074423-003 | CAPTOPRIL | 50MG | TABLET / ORAL | 1996-02-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074423-004 | CAPTOPRIL | 100MG | TABLET / ORAL | 1996-02-13 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074423-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | 1996-02-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074423-002 | CAPTOPRIL | 25MG | TABLET / ORAL | 1996-02-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074423-003 | CAPTOPRIL | 50MG | TABLET / ORAL | 1996-02-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074423-004 | CAPTOPRIL | 100MG | TABLET / ORAL | 1996-02-13 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074423-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | 1996-02-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074423-002 | CAPTOPRIL | 25MG | TABLET / ORAL | 1996-02-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074423-003 | CAPTOPRIL | 50MG | TABLET / ORAL | 1996-02-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074423-004 | CAPTOPRIL | 100MG | TABLET / ORAL | 1996-02-13 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074423-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | 1996-02-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074423-002 | CAPTOPRIL | 25MG | TABLET / ORAL | 1996-02-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074423-003 | CAPTOPRIL | 50MG | TABLET / ORAL | 1996-02-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074423-004 | CAPTOPRIL | 100MG | TABLET / ORAL | 1996-02-13 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074423-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | 1996-02-13 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074423-002 | CAPTOPRIL | 25MG | TABLET / ORAL | 1996-02-13 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074423-003 | CAPTOPRIL | 50MG | TABLET / ORAL | 1996-02-13 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074423-004 | CAPTOPRIL | 100MG | TABLET / ORAL | 1996-02-13 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074423-001 | CAPTOPRIL | 12.5MG | TABLET / ORAL | 1996-02-13 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074423-002 | CAPTOPRIL | 25MG | TABLET / ORAL | 1996-02-13 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074423-003 | CAPTOPRIL | 50MG | TABLET / ORAL | 1996-02-13 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074423-004 | CAPTOPRIL | 100MG | TABLET / ORAL | 1996-02-13 | d06236e962d9… |
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 | CAPTOPRIL | Bryant Ranch Prepack | 563737c5-4d63-4957-8022-e3bc3112dfac | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | Captopril CAPTOPRIL |
| Captopril | CAPTOPRIL | Bryant Ranch Prepack | 66604c8e-f6b6-4cf9-9561-f1cb4af0e0d6 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | Captopril CAPTOPRIL |
| Captopril | CAPTOPRIL | Major Pharmaceuticals | a43a5373-ded9-4912-8c98-edaec8352836 | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | Captopril CAPTOPRIL |
| Captopril | CAPTOPRIL | AiPing Pharmaceutical, Inc. | 3b789f16-b291-4012-be39-af3beec3ff9a | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | Captopril CAPTOPRIL |
| Captopril | CAPTOPRIL | Solco Healthcare US, LLC | 2d3779b0-83d9-4b6f-a043-f7768cd7fce6 | 2025-12-25 | Boxed warning, Warnings, Adverse reactions | Captopril CAPTOPRIL |
| captopril | CAPTOPRIL | Method Pharmaceuticals LLC | 1a91ac7f-b75d-d111-e063-6394a90a2a93 | 2025-12-08 | Boxed warning, Warnings, Adverse reactions | captopril CAPTOPRIL |
| Captopril | CAPTOPRIL | Ajanta Pharma USA Inc. | 1fbc9b28-ff10-4b17-a359-e12b4330747e | 2025-11-27 | Boxed warning, Warnings, Adverse reactions | Captopril CAPTOPRIL |
| Captopril | CAPTOPRIL | Golden State Medical Supply, Inc. | d117c8bd-50a8-7355-e053-2a95a90ac70f | 2025-11-25 | Boxed warning, Warnings, Adverse reactions | Captopril CAPTOPRIL |
| captopril | CAPTOPRIL | Bryant Ranch Prepack | ccbffd30-4b21-4522-bdb8-abba8d592017 | 2025-06-26 | Boxed warning, Warnings, Adverse reactions | captopril CAPTOPRIL |
| Captopril | CAPTOPRIL | AvKARE | 3362b7a8-026a-b277-e063-6394a90a9dc6 | 2025-04-22 | Boxed warning, Warnings, Adverse reactions | Captopril CAPTOPRIL |
| Captopril | CAPTOPRIL | PD-Rx Pharmaceuticals, Inc. | 65ed6e70-f1ee-437e-965c-d1b1fdadd832 | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | Captopril CAPTOPRIL |
| Captopril | CAPTOPRIL | Hikma Pharmaceuticals USA Inc. | 607687f4-63cf-411c-a20b-21d238a6b7a7 | 2024-12-27 | Boxed warning, Warnings, Adverse reactions | Captopril CAPTOPRIL |
| Captopril | CAPTOPRIL | American Health Packaging | 9b54feb0-13cd-46a8-9924-f12880381196 | 2024-12-02 | Boxed warning, Warnings, Adverse reactions | Captopril CAPTOPRIL |
| Captopril | CAPTOPRIL | Camber Pharmaceuticals, Inc. | 5b44ab6e-6cd9-4e12-b9be-d2e4d954acb5 | 2023-12-27 | Boxed warning, Warnings, Adverse reactions | Captopril CAPTOPRIL |
| captopril | CAPTOPRIL | AMICI PHARMACEUTICALS LLC | 1395ba5b-2fc9-41ff-9c43-e0740d781dee | 2022-09-13 | Boxed warning, Warnings, Adverse reactions | captopril CAPTOPRIL |