Application 201192
- Type
- ANDA
- Sponsor
- TORRENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | TABLET;ORAL | 12.5MG;40MG | No | No |
| 002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | TABLET;ORAL | 12.5MG;80MG | No | No |
| 003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | TABLET;ORAL | 25MG;80MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201192-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;40MG | TABLET / ORAL | 2014-02-25 | ||
| A201192-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 12.5MG;80MG | TABLET / ORAL | 2014-02-25 | ||
| A201192-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TELMISARTAN | 25MG;80MG | TABLET / ORAL | 2014-02-25 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A201192-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2014-02-25 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A201192-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2014-02-25 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A201192-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2014-02-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201192-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2014-02-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201192-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2014-02-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201192-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2014-02-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201192-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2014-02-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201192-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2014-02-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201192-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2014-02-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201192-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2014-02-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201192-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2014-02-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201192-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2014-02-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201192-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2014-02-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201192-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2014-02-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201192-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2014-02-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201192-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2014-02-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201192-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2014-02-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201192-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2014-02-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201192-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2014-02-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201192-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2014-02-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201192-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2014-02-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201192-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2014-02-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201192-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2014-02-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201192-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2014-02-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201192-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2014-02-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201192-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2014-02-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201192-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2014-02-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201192-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2014-02-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201192-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2014-02-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201192-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2014-02-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201192-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2014-02-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201192-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2014-02-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201192-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2014-02-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A201192-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2014-02-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A201192-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2014-02-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A201192-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2014-02-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201192-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2014-02-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201192-002 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;80MG | TABLET / ORAL | 2014-02-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201192-003 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 25MG;80MG | TABLET / ORAL | 2014-02-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201192-001 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2014-02-25 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A201192-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A201192-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A201192-003 | AB | 1 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | A201192-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A201192-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A201192-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201192-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201192-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201192-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A201192-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A201192-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A201192-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A201192-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A201192-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A201192-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A201192-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A201192-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A201192-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A201192-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A201192-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A201192-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A201192-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A201192-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A201192-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A201192-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A201192-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A201192-003 | 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 |
|---|---|---|---|---|---|---|
| Telmisartan and Hydrochlorothiazide | TELMISARTAN AND HYDROCHLOROTHIAZIDE | AvKARE | 1b303136-dccd-178b-e063-6394a90a35f8 | 2026-09-08 | Boxed warning, Warnings, Adverse reactions | Telmisartan and Hydrochlorothiazide |
| Telmisartan and Hydrochlorothiazide | TELMISARTAN AND HYDROCHLOROTHIAZIDE | Lupin Pharmaceuticals, Inc. | b88054b3-fafa-4b4e-acf5-5294e5555720 | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | Telmisartan and Hydrochlorothiazide |
| Telmisartan and Hydrochlorothiazide | TELMISARTAN AND HYDROCHLOROTHIAZIDE | Glenmark Pharmaceuticals Inc., USA | 1e55800d-f77c-4950-a6d7-2055f4c7ea17 | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | Telmisartan and Hydrochlorothiazide |
| telmisartan and hydrochlorothiazide | TELMISARTAN AND HYDROCHLOROTHIAZIDE | Lifestar Pharma LLC | 0c1bd0f4-034e-486c-ae46-2855c8c9ebda | 2025-08-20 | Boxed warning, Warnings, Adverse reactions | telmisartan and hydrochlorothiazide |
| TELMISARTAN AND HYDROCHLOROTHIAZIDE | TELMISARTAN AND HYDROCHLOROTHIAZIDE | Solco Healthcare LLC | 47c8eee0-f0b7-4bd8-97e9-0029aa1b37db | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | TELMISARTAN AND HYDROCHLOROTHIAZIDE |
| Telmisartan and Hydrochlorothiazide | TELMISARTAN AND HYDROCHLOROTHIAZIDE | Aurobindo Pharma Limited | 681dfb5c-fc5c-427e-81f6-4b4e934978a2 | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | Telmisartan and Hydrochlorothiazide |
| Telmisartan and Hydrochlorothiazide | TELMISARTAN AND HYDROCHLOROTHIAZIDE | Alembic Pharmaceuticals Inc. | e80f232c-c1c4-4524-a0a5-d23ee0d1f3b7 | 2023-09-15 | Boxed warning, Warnings, Adverse reactions | Telmisartan and Hydrochlorothiazide |
| Telmisartan and Hydrochlorothiazide | TELMISARTAN AND HYDROCHLOROTHIAZIDE | Alembic Pharmaceuticals Limited | 5b476740-e3f0-4f68-b07c-cd9eb2fa27ca | 2023-01-23 | Boxed warning, Warnings, Adverse reactions | Telmisartan and Hydrochlorothiazide |
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 |
|---|---|---|---|---|---|
| 13668-159 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-159 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-159 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-159 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-159 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-159 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-160 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-160 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-160 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-160 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-160 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-160 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-161 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-161 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-161 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-161 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-161 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-161 | telmisartan and hydrochlorthiazide | telmisartan and hydrochlorthiazide | Torrent Pharmaceuticals Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9864 | ORIG | 2014-02-27 |