Application 079135
- Type
- ANDA
- Sponsor
- GLENMARK GENERICS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 2MG;180MG | No | No |
| 002 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 2MG;240MG | No | No |
| 003 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 4MG;240MG | No | No |
| 004 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1MG;240MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079135-001 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | 2MG;180MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | ||
| A079135-002 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | 2MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | ||
| A079135-003 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | 4MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-05-05 | |
| A079135-004 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE | 1MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-08-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079135-001 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;180MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079135-002 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079135-003 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 4MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-05-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079135-004 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 1MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-08-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079135-001 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;180MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079135-002 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079135-003 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 4MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-05-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079135-004 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 1MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-08-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079135-001 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;180MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079135-002 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079135-003 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 4MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-05-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A079135-004 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 1MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-08-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079135-001 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;180MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079135-002 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079135-003 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 4MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-05-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079135-004 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 1MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-08-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079135-001 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;180MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079135-002 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079135-003 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 4MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-05-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079135-004 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 1MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-08-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079135-001 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;180MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079135-002 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079135-003 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 4MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-05-05 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079135-004 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 1MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-08-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079135-001 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;180MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079135-002 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079135-003 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 4MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-05-05 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A079135-004 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 1MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-08-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079135-001 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;180MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079135-002 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079135-003 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 4MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-05-05 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079135-004 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 1MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-08-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A079135-001 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;180MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A079135-002 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A079135-003 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 4MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-05-05 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A079135-004 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 1MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-08-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A079135-001 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;180MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A079135-002 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 2MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-05-26 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A079135-003 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 4MG;240MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2010-05-05 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A079135-004 | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | 1MG;240MG | TABLET, EXTENDED RELEASE / ORAL | 2010-08-30 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A079135-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079135-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079135-003 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079135-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079135-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079135-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A079135-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A079135-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A079135-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A079135-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A079135-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A079135-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A079135-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A079135-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A079135-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A079135-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079135-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079135-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A079135-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079135-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079135-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A079135-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079135-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079135-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079135-004 | 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 |
|---|---|---|---|---|---|---|
| Trandolapril and Verapamil Hydrochloride | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | Glenmark Pharmaceuticals Inc., USA | 39bad727-af4c-4d20-933b-7f287e88099a | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | 079135 ANDA079135 68462-295 68462-294 68462-329 68462-296 |
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 |
|---|---|---|---|---|---|
| 68462-294 | Trandolapril and Verapamil Hydrochloride | Trandolapril and Verapamil Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-294 | Trandolapril and Verapamil Hydrochloride | Trandolapril and Verapamil Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-295 | Trandolapril and Verapamil Hydrochloride | Trandolapril and Verapamil Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-295 | Trandolapril and Verapamil Hydrochloride | Trandolapril and Verapamil Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-296 | Trandolapril and Verapamil Hydrochloride | Trandolapril and Verapamil Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-296 | Trandolapril and Verapamil Hydrochloride | Trandolapril and Verapamil Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-329 | Trandolapril and Verapamil Hydrochloride | Trandolapril and Verapamil Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-329 | Trandolapril and Verapamil Hydrochloride | Trandolapril and Verapamil Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9224 | ORIG | 2010-10-29 |