Application 074587
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 240MG | No | No |
| 002 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 120MG | No | No |
| 003 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 180MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074587-001 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-03-23 | ||
| A074587-002 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1997-02-21 | ||
| A074587-003 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1997-09-09 |
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 | A074587-001 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-03-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074587-002 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1997-02-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074587-003 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1997-09-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074587-001 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-03-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074587-002 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1997-02-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074587-003 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1997-09-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074587-001 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-03-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074587-002 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1997-02-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074587-003 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1997-09-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074587-001 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-03-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074587-002 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1997-02-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074587-003 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1997-09-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074587-001 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-03-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074587-002 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1997-02-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074587-003 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1997-09-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074587-001 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-03-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074587-002 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1997-02-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074587-003 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1997-09-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074587-001 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-03-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074587-002 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1997-02-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074587-003 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1997-09-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074587-001 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-03-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074587-002 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1997-02-21 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074587-003 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1997-09-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074587-001 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-03-23 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074587-002 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1997-02-21 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074587-003 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1997-09-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074587-001 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-03-23 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074587-002 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1997-02-21 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074587-003 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1997-09-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074587-001 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-03-23 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074587-002 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1997-02-21 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074587-003 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1997-09-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074587-001 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-03-23 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074587-002 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1997-02-21 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074587-003 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1997-09-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074587-001 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-03-23 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074587-002 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 1997-02-21 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074587-003 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1997-09-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074587-001 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-03-23 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A074587-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A074587-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A074587-003 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074587-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074587-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074587-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A074587-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A074587-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A074587-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A074587-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A074587-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A074587-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A074587-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A074587-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A074587-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A074587-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A074587-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A074587-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A074587-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A074587-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A074587-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A074587-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A074587-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A074587-003 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-3043 | Verapamil Hydrochloride | verapamil hydrochloride | Teva Pharmaceuticals USA Inc | ANDA | Current |
| 0093-3044 | Verapamil Hydrochloride | verapamil hydrochloride | Teva Pharmaceuticals USA Inc | ANDA | Current |
| 0093-3045 | Verapamil Hydrochloride | verapamil hydrochloride | Teva Pharmaceuticals USA Inc | ANDA | Current |
| 0378-1411 | Verapamil Hydrochloride | verapamil hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1411 | Verapamil Hydrochloride | verapamil hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2120 | Verapamil Hydrochloride | verapamil hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2120 | Verapamil Hydrochloride | verapamil hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2180 | Verapamil Hydrochloride | verapamil hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2180 | Verapamil Hydrochloride | verapamil hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 43353-599 | Verapamil Hydrochloride | verapamil hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-599 | Verapamil Hydrochloride | verapamil hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-600 | Verapamil Hydrochloride | verapamil hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-600 | Verapamil Hydrochloride | verapamil hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-921 | Verapamil Hydrochloride | verapamil hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 51079-869 | Verapamil Hydrochloride | verapamil hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-894 | Verapamil Hydrochloride | verapamil hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-899 | Verapamil Hydrochloride | verapamil hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 60429-197 | Verapamil Hydrochloride | verapamil hydrochloride | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-198 | Verapamil Hydrochloride | verapamil hydrochloride | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-198 | Verapamil Hydrochloride | verapamil hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-199 | Verapamil Hydrochloride | verapamil hydrochloride | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-199 | Verapamil Hydrochloride | verapamil hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 66267-211 | Verapamil Hydrochloride | verapamil hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-211 | Verapamil Hydrochloride | verapamil hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68151-0693 | Verapamil Hydrochloride | verapamil hydrochloride | Carilion Materials Management | ANDA | Current |
| 70518-1179 | Verapamil Hydrochloride | verapamil hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1179 | Verapamil Hydrochloride | verapamil hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-214 | Verapamil Hydrochloride | verapamil hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-214 | Verapamil Hydrochloride | verapamil hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-0638 | Verapamil Hydrochloride | verapamil hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0638 | Verapamil Hydrochloride | verapamil hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0638 | Verapamil Hydrochloride | verapamil hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0638 | Verapamil Hydrochloride | verapamil hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0703 | Verapamil Hydrochloride | verapamil hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0703 | Verapamil Hydrochloride | verapamil hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0757 | Verapamil Hydrochloride | verapamil hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0757 | Verapamil Hydrochloride | verapamil hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0927 | Verapamil Hydrochloride | verapamil hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0927 | Verapamil Hydrochloride | verapamil hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0927 | Verapamil Hydrochloride | verapamil hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0927 | Verapamil Hydrochloride | verapamil hydrochloride | Bryant Ranch Prepack | ANDA | Current |