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 | PD-Rx Pharmaceuticals, Inc. | 3c215e6c-d85a-4102-a1c2-f00fa3169a55 | 2026-01-08 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 9d529fe3-7b5c-4dde-9a8c-440a969df359 | 2026-01-05 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Northwind Health Company, LLC | f2f059a1-0cf9-a5d6-e053-2a95a90a3dab | 2026-01-01 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Northwind Health Company, LLC | db990ce1-b193-4a81-e053-2a95a90a627b | 2026-01-01 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Northwind Health Company, LLC | adc77fea-db39-aac5-e053-2995a90ad458 | 2026-01-01 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Northwind Health Company, LLC | e08c07bf-58b4-6fa2-e053-2a95a90aca32 | 2026-01-01 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | Northwind Health Company, LLC | 62c3aadf-412e-41a5-9e57-2c48d962f90a | 2026-01-01 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | Northwind Health Company, LLC | f7814f9a-e589-4041-e053-6294a90a29e3 | 2026-01-01 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | ProPharma Distribution | 386ae2d7-ddf7-a753-e063-6294a90ab45e | 2025-12-18 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Chartwell RX, LLC | ebc9a09a-7b5f-4df6-ace7-31185d469b28 | 2025-12-10 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | Glenmark Pharmaceuticals Inc., USA | ba1bf1ae-9347-4d17-998b-14bf7b5984ce | 2025-12-02 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Henry Schein, Inc. | 262608c5-843a-4122-b858-5affdc670389 | 2025-11-07 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Henry Schein, Inc. | 9650680c-89ae-451b-aa75-4d34158866e7 | 2025-11-07 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | REMEDYREPACK INC. | d7c29dfd-3968-41ac-a081-e670f9bd605c | 2025-11-03 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | Medical Purchasing Solutions, LLC. | 424f538f-8785-8279-e063-6394a90aeb4c | 2025-10-29 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | af1249b0-e889-4f02-bdc2-54862de0545e | 2025-10-07 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | b0eeada4-1010-4c11-b408-29f9a1af23c0 | 2025-10-07 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | c7a54ee0-80c0-4c7e-a6a3-cb60142f860c | 2025-10-02 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Teva Pharmaceuticals Inc | 0742cf97-601b-4c13-a6c3-1a6a616ed292 | 2025-09-22 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Mylan Institutional Inc. | 3bee2d26-138c-4641-a217-a38d3d657461 | 2025-07-22 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.