Application 209261
- Type
- ANDA
- Sponsor
- UNICHEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VALSARTAN | VALSARTAN | TABLET;ORAL | 40MG | No | No |
| 002 | VALSARTAN | VALSARTAN | TABLET;ORAL | 80MG | No | No |
| 003 | VALSARTAN | VALSARTAN | TABLET;ORAL | 160MG | No | No |
| 004 | VALSARTAN | VALSARTAN | TABLET;ORAL | 320MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209261-001 | VALSARTAN | VALSARTAN | 40MG | TABLET / ORAL | 2018-05-04 | ||
| A209261-002 | VALSARTAN | VALSARTAN | 80MG | TABLET / ORAL | 2018-05-04 | ||
| A209261-003 | VALSARTAN | VALSARTAN | 160MG | TABLET / ORAL | 2018-05-04 | ||
| A209261-004 | VALSARTAN | VALSARTAN | 320MG | TABLET / ORAL | 2018-05-04 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A209261-001 | VALSARTAN | 40MG | TABLET / ORAL | 2018-05-04 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A209261-002 | VALSARTAN | 80MG | TABLET / ORAL | 2018-05-04 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A209261-003 | VALSARTAN | 160MG | TABLET / ORAL | 2018-05-04 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A209261-004 | VALSARTAN | 320MG | TABLET / ORAL | 2018-05-04 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A209261-001 | VALSARTAN | 40MG | TABLET / ORAL | 2018-05-04 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A209261-002 | VALSARTAN | 80MG | TABLET / ORAL | 2018-05-04 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A209261-003 | VALSARTAN | 160MG | TABLET / ORAL | 2018-05-04 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A209261-004 | VALSARTAN | 320MG | TABLET / ORAL | 2018-05-04 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A209261-001 | VALSARTAN | 40MG | TABLET / ORAL | 2018-05-04 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A209261-002 | VALSARTAN | 80MG | TABLET / ORAL | 2018-05-04 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A209261-003 | VALSARTAN | 160MG | TABLET / ORAL | 2018-05-04 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A209261-004 | VALSARTAN | 320MG | TABLET / ORAL | 2018-05-04 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209261-001 | VALSARTAN | 40MG | TABLET / ORAL | 2018-05-04 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209261-002 | VALSARTAN | 80MG | TABLET / ORAL | 2018-05-04 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209261-003 | VALSARTAN | 160MG | TABLET / ORAL | 2018-05-04 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209261-004 | VALSARTAN | 320MG | TABLET / ORAL | 2018-05-04 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A209261-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A209261-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A209261-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A209261-004 | AB | 1 | 74a2ff9319b5… |
| 2020-11-12 02:37 UTC | 2020-11 | A209261-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A209261-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A209261-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A209261-004 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A209261-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A209261-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A209261-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A209261-004 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A209261-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A209261-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A209261-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A209261-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A209261-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A209261-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A209261-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A209261-004 | AB | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Valsartan | VALSARTAN | Unichem Pharmaceuticals (USA), Inc. | 93b82a9f-dc0a-4f7d-b0d4-4adf0d917b7e | 2021-09-09 | Boxed warning, Warnings, Adverse reactions | 209261 ANDA209261 29300-233 29300-234 29300-235 29300-232 |
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 |
|---|---|---|---|---|---|
| 29300-232 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-232 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-232 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-232 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-232 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-233 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-233 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-233 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-233 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-233 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-234 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-234 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-234 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-234 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-234 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-235 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-235 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-235 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-235 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-235 | Valsartan | Valsartan | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |