Application 204164
- Type
- ANDA
- Sponsor
- JUBILANT GENERICS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TELMISARTAN | TELMISARTAN | TABLET;ORAL | 20MG | No | No |
| 002 | TELMISARTAN | TELMISARTAN | TABLET;ORAL | 40MG | No | No |
| 003 | TELMISARTAN | TELMISARTAN | TABLET;ORAL | 80MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204164-001 | TELMISARTAN | TELMISARTAN | 20MG | TABLET / ORAL | AB | 2016-08-22 | |
| A204164-002 | TELMISARTAN | TELMISARTAN | 40MG | TABLET / ORAL | AB | 2016-08-22 | |
| A204164-003 | TELMISARTAN | TELMISARTAN | 80MG | TABLET / ORAL | AB | 2016-08-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204164-001 | AB |
| A204164-002 | AB |
| A204164-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A204164-001 | TELMISARTAN | 20MG | TABLET / ORAL | AB | 2016-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204164-002 | TELMISARTAN | 40MG | TABLET / ORAL | AB | 2016-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204164-003 | TELMISARTAN | 80MG | TABLET / ORAL | AB | 2016-08-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204164-001 | TELMISARTAN | 20MG | TABLET / ORAL | AB | 2016-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204164-002 | TELMISARTAN | 40MG | TABLET / ORAL | AB | 2016-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204164-003 | TELMISARTAN | 80MG | TABLET / ORAL | AB | 2016-08-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204164-001 | TELMISARTAN | 20MG | TABLET / ORAL | 2016-08-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204164-002 | TELMISARTAN | 40MG | TABLET / ORAL | 2016-08-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204164-003 | TELMISARTAN | 80MG | TABLET / ORAL | 2016-08-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204164-001 | TELMISARTAN | 20MG | TABLET / ORAL | 2016-08-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204164-002 | TELMISARTAN | 40MG | TABLET / ORAL | 2016-08-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204164-003 | TELMISARTAN | 80MG | TABLET / ORAL | 2016-08-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204164-001 | TELMISARTAN | 20MG | TABLET / ORAL | 2016-08-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204164-002 | TELMISARTAN | 40MG | TABLET / ORAL | 2016-08-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204164-003 | TELMISARTAN | 80MG | TABLET / ORAL | 2016-08-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204164-001 | TELMISARTAN | 20MG | TABLET / ORAL | 2016-08-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204164-002 | TELMISARTAN | 40MG | TABLET / ORAL | 2016-08-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204164-003 | TELMISARTAN | 80MG | TABLET / ORAL | 2016-08-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204164-001 | TELMISARTAN | 20MG | TABLET / ORAL | 2016-08-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204164-002 | TELMISARTAN | 40MG | TABLET / ORAL | 2016-08-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204164-003 | TELMISARTAN | 80MG | TABLET / ORAL | 2016-08-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204164-001 | TELMISARTAN | 20MG | TABLET / ORAL | 2016-08-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204164-002 | TELMISARTAN | 40MG | TABLET / ORAL | 2016-08-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204164-003 | TELMISARTAN | 80MG | TABLET / ORAL | 2016-08-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204164-001 | TELMISARTAN | 20MG | TABLET / ORAL | 2016-08-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204164-002 | TELMISARTAN | 40MG | TABLET / ORAL | 2016-08-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204164-003 | TELMISARTAN | 80MG | TABLET / ORAL | 2016-08-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204164-001 | TELMISARTAN | 20MG | TABLET / ORAL | 2016-08-22 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204164-002 | TELMISARTAN | 40MG | TABLET / ORAL | 2016-08-22 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204164-003 | TELMISARTAN | 80MG | TABLET / ORAL | 2016-08-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204164-001 | TELMISARTAN | 20MG | TABLET / ORAL | 2016-08-22 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204164-002 | TELMISARTAN | 40MG | TABLET / ORAL | 2016-08-22 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204164-003 | TELMISARTAN | 80MG | TABLET / ORAL | 2016-08-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204164-001 | TELMISARTAN | 20MG | TABLET / ORAL | 2016-08-22 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204164-002 | TELMISARTAN | 40MG | TABLET / ORAL | 2016-08-22 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204164-003 | TELMISARTAN | 80MG | TABLET / ORAL | 2016-08-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204164-001 | TELMISARTAN | 20MG | TABLET / ORAL | 2016-08-22 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204164-002 | TELMISARTAN | 40MG | TABLET / ORAL | 2016-08-22 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204164-003 | TELMISARTAN | 80MG | TABLET / ORAL | 2016-08-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204164-001 | TELMISARTAN | 20MG | TABLET / ORAL | 2016-08-22 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A204164-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204164-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204164-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204164-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204164-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204164-003 | AB | 1 | 31067a03dcf5… |
| 2019-12-13 00:20 UTC | 2019-12 | A204164-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A204164-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A204164-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A204164-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A204164-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A204164-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A204164-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A204164-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A204164-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A204164-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A204164-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A204164-003 | AB | 1 | ea99ee380514… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A204164-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A204164-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A204164-003 | 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 |
|---|---|---|---|---|---|---|
| Telmisartan | TELMISARTAN | Jubilant Cadista Pharmacuticals Inc. | e1a907a7-fad9-a860-8639-4c6136c85734 | 2025-01-15 | Boxed warning, Warnings, Adverse reactions | 204164 ANDA204164 59746-441 59746-439 59746-440 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59746-439 | Telmisartan | Telmisartan | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-440 | Telmisartan | Telmisartan | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-441 | Telmisartan | Telmisartan | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |