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 | NuCare Pharmaceuticals,Inc. | 7b321aa1-1b53-26d5-e053-2991aa0a1373 | 2024-06-12 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Bryant Ranch Prepack | 2f232216-db62-4dc6-a5a7-9139d7ac7589 | 2024-05-24 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Bryant Ranch Prepack | 006cf920-04ae-0b53-cb91-85481972abc2 | 2024-05-22 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | HF Acquisition Co. LLC, DBA HealthFirst | 74d94dbf-0567-6c15-e053-2991aa0ac6e4 | 2024-02-22 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 951c7fd7-10ef-2b07-e053-2995a90aaffd | 2024-02-19 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Actavis Pharma, Inc. | a0343397-897b-46d6-943f-a87e07e1de10 | 2024-01-30 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Bryant Ranch Prepack | d4a6c046-81fe-4b2a-9cb0-adb3f037eec7 | 2024-01-26 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Bryant Ranch Prepack | 2f839b5c-b8e7-40df-887f-7df94326fc7b | 2023-12-08 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Eugia US LLC | def3b9ba-523d-4b83-a80d-fa6f362e111c | 2023-07-24 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | A-S Medication Solutions | 5467dad4-f3ba-4036-b5f4-4d2d4d5abc34 | 2023-06-12 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 6685248d-908e-cd07-e053-2a91aa0ac718 | 2023-05-30 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 9e04440f-4cee-990b-e053-2995a90a09e1 | 2023-05-10 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 9f19a5b4-286c-2c3f-e053-2a95a90a51df | 2023-05-09 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | A-S Medication Solutions | f00c1caf-68b6-40c1-a1fa-72d17d2cf44f | 2023-05-04 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Medical Purchasing Solutions, LLC | a2a4b816-417c-4a37-e053-2995a90a0220 | 2023-05-03 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Proficient Rx LP | 343724eb-e80b-4729-80e7-6b8028713ea1 | 2023-05-01 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Medical Purchasing Solutions, LLC | bfc7fa37-1ee3-5eb2-e053-2995a90a5622 | 2023-04-27 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Sagent Pharmaceuticals | a76b2cff-7029-4607-88db-9921ec2842b6 | 2023-04-25 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Medical Purchasing Solutions, LLC | e99a1aea-cd0a-59cb-e053-2a95a90a1147 | 2023-04-24 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Zydus Lifesciences Limited | cccf4a5f-6c5d-4d52-97e4-fe7a2dbd28d8 | 2022-11-05 | VERAPAMIL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.