Application 203685
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 75MG | No | No |
| 002 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 150MG | No | No |
| 003 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 300MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203685-001 | IRBESARTAN | IRBESARTAN | 75MG | TABLET / ORAL | 2015-12-10 | ||
| A203685-002 | IRBESARTAN | IRBESARTAN | 150MG | TABLET / ORAL | 2015-12-10 | ||
| A203685-003 | IRBESARTAN | IRBESARTAN | 300MG | TABLET / ORAL | 2015-12-10 |
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 | A203685-001 | IRBESARTAN | 75MG | TABLET / ORAL | 2015-12-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203685-002 | IRBESARTAN | 150MG | TABLET / ORAL | 2015-12-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203685-003 | IRBESARTAN | 300MG | TABLET / ORAL | 2015-12-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203685-001 | IRBESARTAN | 75MG | TABLET / ORAL | 2015-12-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203685-002 | IRBESARTAN | 150MG | TABLET / ORAL | 2015-12-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203685-003 | IRBESARTAN | 300MG | TABLET / ORAL | 2015-12-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203685-001 | IRBESARTAN | 75MG | TABLET / ORAL | 2015-12-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203685-002 | IRBESARTAN | 150MG | TABLET / ORAL | 2015-12-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203685-003 | IRBESARTAN | 300MG | TABLET / ORAL | 2015-12-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203685-001 | IRBESARTAN | 75MG | TABLET / ORAL | 2015-12-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203685-002 | IRBESARTAN | 150MG | TABLET / ORAL | 2015-12-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203685-003 | IRBESARTAN | 300MG | TABLET / ORAL | 2015-12-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203685-001 | IRBESARTAN | 75MG | TABLET / ORAL | 2015-12-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203685-002 | IRBESARTAN | 150MG | TABLET / ORAL | 2015-12-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203685-003 | IRBESARTAN | 300MG | TABLET / ORAL | 2015-12-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203685-001 | IRBESARTAN | 75MG | TABLET / ORAL | 2015-12-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203685-002 | IRBESARTAN | 150MG | TABLET / ORAL | 2015-12-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203685-003 | IRBESARTAN | 300MG | TABLET / ORAL | 2015-12-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203685-001 | IRBESARTAN | 75MG | TABLET / ORAL | 2015-12-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203685-002 | IRBESARTAN | 150MG | TABLET / ORAL | 2015-12-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203685-003 | IRBESARTAN | 300MG | TABLET / ORAL | 2015-12-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203685-001 | IRBESARTAN | 75MG | TABLET / ORAL | 2015-12-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203685-002 | IRBESARTAN | 150MG | TABLET / ORAL | 2015-12-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203685-003 | IRBESARTAN | 300MG | TABLET / ORAL | 2015-12-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203685-001 | IRBESARTAN | 75MG | TABLET / ORAL | 2015-12-10 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203685-002 | IRBESARTAN | 150MG | TABLET / ORAL | 2015-12-10 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203685-003 | IRBESARTAN | 300MG | TABLET / ORAL | 2015-12-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A203685-001 | IRBESARTAN | 75MG | TABLET / ORAL | 2015-12-10 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A203685-002 | IRBESARTAN | 150MG | TABLET / ORAL | 2015-12-10 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A203685-003 | IRBESARTAN | 300MG | TABLET / ORAL | 2015-12-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203685-001 | IRBESARTAN | 75MG | TABLET / ORAL | 2015-12-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203685-002 | IRBESARTAN | 150MG | TABLET / ORAL | 2015-12-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203685-003 | IRBESARTAN | 300MG | TABLET / ORAL | 2015-12-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203685-001 | IRBESARTAN | 75MG | TABLET / ORAL | 2015-12-10 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203685-002 | IRBESARTAN | 150MG | TABLET / ORAL | 2015-12-10 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203685-003 | IRBESARTAN | 300MG | TABLET / ORAL | 2015-12-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203685-001 | IRBESARTAN | 75MG | TABLET / ORAL | 2015-12-10 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203685-002 | IRBESARTAN | 150MG | TABLET / ORAL | 2015-12-10 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203685-003 | IRBESARTAN | 300MG | TABLET / ORAL | 2015-12-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A203685-001 | IRBESARTAN | 75MG | TABLET / ORAL | 2015-12-10 | 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 |
|---|---|---|---|---|---|---|
| Irbesartan | IRBESARTAN | Macleods Pharmaceuticals Limited | e8635a1c-ae06-4e23-99f7-e704f91d6f43 | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |
| IRBESARTAN | IRBESARTAN | Hisun Pharmaceuticals USA Inc. | 61ab1b6e-c849-49ca-a3f0-150774db649d | 2026-08-05 | Boxed warning, Warnings, Adverse reactions | IRBESARTAN IRBESARTAN |
| Irbesartan | IRBESARTAN | REMEDYREPACK INC. | 5b259fdd-ca4c-49c9-a50d-86066f5b0746 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |
| Irbesartan | IRBESARTAN | REMEDYREPACK INC. | 029a90b6-0722-49be-8400-3ec29526aafd | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |
| Irbesartan | IRBESARTAN | REMEDYREPACK INC. | 9adacfa2-2814-4deb-9e34-c3b3c8dcd41a | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |
| IRBESARTAN | IRBESARTAN | Chartwell RX, LLC | 6eb0cb56-2e51-45ef-9fd5-5646cf9f78a3 | 2026-06-18 | Boxed warning, Warnings, Adverse reactions | IRBESARTAN IRBESARTAN |
| Irbesartan | IRBESARTAN | Bryant Ranch Prepack | 7e0ddb7b-80c5-47ab-afee-c74bb735e829 | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |
| Irbesartan | IRBESARTAN | Bryant Ranch Prepack | 21dd9a41-93c7-470c-94ed-f4c24e3d5633 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |
| Irbesartan | IRBESARTAN | Preferred Pharmaceuticals Inc. | 197871da-e0c5-49a9-8dd0-34a8c2685c6b | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |
| IRBESARTAN | IRBESARTAN | Jubilant Cadista Pharmaceuticals Inc. | 068224c4-a34d-32d7-bb2a-7eed44ccf7d3 | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | IRBESARTAN IRBESARTAN |
| Irbesartan | IRBESARTAN | NorthStar RxLLC | 08c85ada-de6f-4cff-bc81-2332a22bef45 | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |
| Irbesartan | IRBESARTAN | REMEDYREPACK INC. | 0c1fc197-c2d9-453c-b79f-b53de89c188b | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |
| Irbesartan | IRBESARTAN | REMEDYREPACK INC. | bb58acb0-2dc0-45ee-86bb-b405b1b75cff | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |
| Irbesartan | IRBESARTAN | Camber Pharmaceuticals, Inc. | 33416f1e-adee-4a45-b6fe-1fc39044e307 | 2026-03-12 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |
| Avapro | IRBESARTAN | Sanofi-Aventis U.S. LLC | 7885b2a8-be4e-48ab-8113-4e6ab791eb98 | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | IRBESARTAN |
| Irbesartan | IRBESARTAN | Aurobindo Pharma Limited | 2113a901-2612-4557-b86d-3afc006fb8bb | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |
| Irbesartan | IRBESARTAN | Bryant Ranch Prepack | bc07bbf5-b1c6-4854-b6af-e06520c20728 | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |
| Irbesartan | IRBESARTAN | Amneal Pharmaceuticals LLC | 8c9bb449-6341-4f24-9d38-6ca952e07122 | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |
| Irbesartan | IRBESARTAN | Bryant Ranch Prepack | ed789dc1-0b39-4efc-990d-7b6b43a8b3ba | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |
| Irbesartan | IRBESARTAN | Bryant Ranch Prepack | 44b72da1-4434-461f-8e3c-264ad46f85df | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | Irbesartan IRBESARTAN |