Application 201586
- Type
- ANDA
- Sponsor
- LUPIN LTD
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 |
|---|---|---|---|---|---|---|---|
| A201586-001 | TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | EQ 5MG BASE;40MG | TABLET / ORAL | 2014-01-08 | ||
| A201586-002 | TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | EQ 10MG BASE;40MG | TABLET / ORAL | 2014-01-08 | ||
| A201586-003 | TELMISARTAN AND AMLODIPINE | AMLODIPINE BESYLATE; TELMISARTAN | EQ 5MG BASE;80MG | TABLET / ORAL | 2014-01-08 | ||
| A201586-004 | 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 | A201586-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A201586-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A201586-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A201586-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201586-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | 2014-01-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201586-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | 2014-01-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201586-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | 2014-01-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201586-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | 2014-01-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201586-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201586-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | 2014-01-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201586-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | 2014-01-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201586-004 | 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 | A201586-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | AB | 2014-01-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201586-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | AB | 2014-01-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201586-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | AB | 2014-01-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201586-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | AB | 2014-01-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201586-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | AB | 2014-01-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201586-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | AB | 2014-01-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201586-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | AB | 2014-01-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201586-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | AB | 2014-01-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201586-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | AB | 2014-01-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201586-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | AB | 2014-01-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201586-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | AB | 2014-01-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201586-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | AB | 2014-01-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201586-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | AB | 2014-01-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201586-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | AB | 2014-01-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201586-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | AB | 2014-01-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201586-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | AB | 2014-01-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201586-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | AB | 2014-01-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201586-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | AB | 2014-01-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201586-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | AB | 2014-01-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201586-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | AB | 2014-01-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201586-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | AB | 2014-01-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201586-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | AB | 2014-01-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201586-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | AB | 2014-01-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201586-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | AB | 2014-01-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201586-001 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;40MG | TABLET / ORAL | AB | 2014-01-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201586-002 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;40MG | TABLET / ORAL | AB | 2014-01-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201586-003 | TELMISARTAN AND AMLODIPINE | EQ 5MG BASE;80MG | TABLET / ORAL | AB | 2014-01-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201586-004 | TELMISARTAN AND AMLODIPINE | EQ 10MG BASE;80MG | TABLET / ORAL | AB | 2014-01-08 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-03-12 10:30 UTC | 2021-03 | A201586-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A201586-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A201586-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A201586-004 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A201586-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A201586-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A201586-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A201586-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A201586-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A201586-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A201586-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A201586-004 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A201586-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A201586-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A201586-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A201586-004 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A201586-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A201586-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A201586-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A201586-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A201586-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A201586-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A201586-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A201586-004 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201586-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201586-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201586-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201586-004 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A201586-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A201586-002 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A201586-003 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A201586-004 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A201586-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A201586-002 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A201586-003 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A201586-004 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201586-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201586-002 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201586-003 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201586-004 | AB | 1 | a72a2bbeb626… |
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 | 201586 ANDA201586 68180-199 68180-197 68180-198 68180-196 |
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 |
|---|---|---|---|---|---|
| 42291-793 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | AvKARE, Inc. | ANDA | Current |
| 42291-793 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | AvKARE | ANDA | Current |
| 42291-794 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | AvKARE, Inc. | ANDA | Current |
| 42291-794 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | AvKARE | ANDA | Current |
| 42291-795 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | AvKARE, Inc. | ANDA | Current |
| 42291-795 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | AvKARE | ANDA | Current |
| 42291-796 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | AvKARE, Inc. | ANDA | Current |
| 42291-796 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | AvKARE | ANDA | Current |
| 68180-196 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-196 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-197 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-197 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-198 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-198 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-199 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-199 | Telmisartan and Amlodipine | Telmisartan and Amlodipine | Lupin Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32119 | ORIG | 2014-08-29 |