Application 202517
- Type
- ANDA
- Sponsor
- TORRENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | TABLET;ORAL | EQ 5MG BASE;40MG | No | No |
| 002 | TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | TABLET;ORAL | EQ 10MG BASE;40MG | No | No |
| 003 | TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | TABLET;ORAL | EQ 5MG BASE;80MG | No | No |
| 004 | TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | TABLET;ORAL | EQ 10MG BASE;80MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202517-001 | TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | EQ 5MG BASE;40MG | TABLET / ORAL | 2014-01-08 | ||
| A202517-002 | TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | EQ 10MG BASE;40MG | TABLET / ORAL | 2014-01-08 | ||
| A202517-003 | TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | EQ 5MG BASE;80MG | TABLET / ORAL | 2014-01-08 | ||
| A202517-004 | TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | EQ 10MG BASE;80MG | TABLET / ORAL | 2014-01-08 |
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 | A202517-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A202517-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A202517-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A202517-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202517-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | 2014-01-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202517-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | 2014-01-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202517-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | 2014-01-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202517-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | 2014-01-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202517-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202517-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202517-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202517-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202517-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202517-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202517-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202517-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202517-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202517-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202517-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202517-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202517-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | 2014-01-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202517-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | 2014-01-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202517-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | 2014-01-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202517-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | 2014-01-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202517-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | 2014-01-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202517-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | 2014-01-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202517-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | 2014-01-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202517-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | 2014-01-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202517-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202517-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202517-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202517-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202517-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202517-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202517-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202517-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202517-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202517-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202517-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202517-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-04-04 05:41 UTC | 2022-04 | A202517-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202517-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202517-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202517-004 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A202517-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202517-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202517-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202517-004 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A202517-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202517-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202517-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202517-004 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A202517-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202517-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202517-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202517-004 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202517-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202517-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202517-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202517-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A202517-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A202517-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A202517-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A202517-004 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A202517-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A202517-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A202517-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A202517-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A202517-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A202517-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A202517-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A202517-004 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A202517-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A202517-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A202517-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A202517-004 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A202517-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A202517-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A202517-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A202517-004 | AB | 1 | b00525d2431f… |
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 Amlodipine | TELMISARTAN AND AMLODIPINE | Lupin Pharmaceuticals, Inc. | a97fefa6-99e6-4eb7-9393-ab2252a2c7d8 | 2023-12-15 | Boxed warning, Warnings, Adverse reactions | Telmisartan and Amlodipine |
| Telmisartan and Amlodipine | TELMISARTAN AND AMLODIPINE | Alembic Pharmaceuticals Limited | 15b438b4-4874-43f4-a50a-4e6f3e5530ac | 2023-01-30 | Boxed warning, Warnings, Adverse reactions | Telmisartan and Amlodipine |
| Telmisartan and Amlodipine | TELMISARTAN AND AMLODIPINE | Mylan Pharmaceuticals Inc. | ca60a4d5-ace7-4889-94ee-e2265fd63811 | 2018-11-14 | Boxed warning, Warnings, Adverse reactions | Telmisartan and Amlodipine |
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 |
|---|---|---|---|---|---|
| 13668-343 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-343 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-343 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-344 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-344 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-344 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-345 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-345 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-345 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-346 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-346 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-346 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Torrent Pharmaceuticals Limited | ANDA | Current |