Application 020552
- Type
- NDA
- Sponsor
- GD SEARLE LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COVERA-HS | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 180MG | No | No |
| 002 | COVERA-HS | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 240MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020552-001 | COVERA-HS | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | ||
| N020552-002 | COVERA-HS | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 |
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 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020552-001 | COVERA-HS | 180MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020552-002 | COVERA-HS | 240MG | TABLET, EXTENDED RELEASE / ORAL | 1996-02-26 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Golden State Medical Supply, Inc. | 3283bba6-05dd-3766-e063-6394a90ada69 | 2025-04-11 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Chartwell RX, LLC | 18f6d349-8c5c-4443-ac65-16bf6619ecdc | 2025-03-25 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | fe0583bf-9986-e01e-e053-6294a90a0b26 | 2025-02-04 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | fe05b8d8-fdee-903b-e053-6394a90a2e05 | 2025-02-04 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | febce7aa-7f5a-e0c1-e053-6394a90aebc4 | 2025-02-04 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Caplin Steriles Limited | e18cc04c-a808-4d92-9b66-762cd787abc5 | 2025-01-16 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | d23c757d-39f8-48c3-ba63-df2cbe58c516 | 2025-01-09 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 1076a3ef-de02-487f-8117-b4e80495db29 | 2024-12-26 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | fdb7cd57-d33c-f5a3-e053-6294a90aff31 | 2024-12-13 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | a9a1a522-231b-41a1-95c6-0c75dbb62f47 | 2024-12-06 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | c87c7f7e-cdf5-42c7-a831-a7515d2d51d6 | 2024-12-06 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Wilshire Pharmaceuticals, Inc. | 5f665d08-e1e4-422a-88c2-d8834abf9e1a | 2024-11-27 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Wilshire Pharmaceuticals, Inc. | f9399858-fd7a-4b73-8759-3e5bf3af2666 | 2024-11-27 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | FRESENIUS KABI USA, LLC | 38ca9270-5538-467a-a3e9-c27968f3aafe | 2024-11-08 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Bryant Ranch Prepack | 660a83a9-60be-42d5-bc70-fe384e93beaa | 2024-10-24 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | A-S Medication Solutions | 0b00ec93-0bb3-4181-a6ef-45206f0621f7 | 2024-10-16 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 3f14442c-8178-0bad-e054-00144ff8d46c | 2024-08-14 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | a58f5f77-7e88-d622-e053-2a95a90a0d35 | 2024-07-17 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Amneal Pharmaceuticals LLC | 9055ed6b-f466-4f38-a9d9-f22e9ac97ad4 | 2024-07-10 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Bryant Ranch Prepack | f88dfe56-08bc-46b1-8f05-f886a16a89bc | 2024-07-08 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.