Application 203630
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | TABLET;ORAL | 12.5MG;150MG | No | No |
| 002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | TABLET;ORAL | 12.5MG;300MG | No | No |
| 003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | TABLET;ORAL | 25MG;300MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203630-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET / ORAL | AB | 2013-02-22 | |
| A203630-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET / ORAL | AB | 2013-02-22 | |
| A203630-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 25MG;300MG | TABLET / ORAL | AB | 2016-03-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203630-001 | AB |
| A203630-002 | AB |
| A203630-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A203630-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2013-02-22 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A203630-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2013-02-22 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A203630-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | AB | 2016-03-31 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A203630-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2013-02-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203630-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2013-02-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203630-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | AB | 2016-03-31 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A203630-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2013-02-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203630-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2013-02-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203630-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | AB | 2016-03-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203630-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2013-02-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203630-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2013-02-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203630-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | AB | 2016-03-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203630-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2013-02-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203630-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2013-02-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203630-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | AB | 2016-03-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203630-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2013-02-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203630-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2013-02-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203630-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | AB | 2016-03-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203630-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2013-02-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203630-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2013-02-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203630-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | AB | 2016-03-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203630-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2013-02-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203630-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2013-02-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203630-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | AB | 2016-03-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203630-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2013-02-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203630-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2013-02-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203630-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | AB | 2016-03-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203630-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2013-02-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203630-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2013-02-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203630-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | AB | 2016-03-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203630-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2013-02-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203630-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2013-02-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203630-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | AB | 2016-03-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203630-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2013-02-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203630-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2013-02-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203630-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | AB | 2016-03-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203630-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2013-02-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203630-002 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;300MG | TABLET / ORAL | AB | 2013-02-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203630-003 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 25MG;300MG | TABLET / ORAL | AB | 2016-03-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203630-001 | IRBESARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;150MG | TABLET / ORAL | AB | 2013-02-22 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A203630-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A203630-002 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A203630-003 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A203630-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A203630-002 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A203630-003 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A203630-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A203630-002 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A203630-003 | AB | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203630-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203630-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A203630-003 | AB | 1 | a50c72e98297… |
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 and Hydrochlorothiazide | IRBESARTAN AND HYDROCHLOROTHIAZIDE | Aurobindo Pharma Limited | 466dd0d2-9815-4c3e-b66b-d0732b3ba8e9 | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | 203630 ANDA203630 65862-629 65862-630 65862-631 |
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 |
|---|---|---|---|---|---|
| 64980-382 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-383 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-384 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 65862-629 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-629 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-629 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-629 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-629 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-629 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-630 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-630 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-630 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-630 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-630 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-630 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-631 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-631 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-631 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-631 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-631 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-631 | Irbesartan and Hydrochlorothiazide | Irbesartan and Hydrochlorothiazide | Aurobindo Pharma Limited | ANDA | Current |