Application 018817
- Type
- NDA
- Sponsor
- GD SEARLE LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CALAN | VERAPAMIL HYDROCHLORIDE | TABLET;ORAL | 80MG | Yes | No |
| 002 | CALAN | VERAPAMIL HYDROCHLORIDE | TABLET;ORAL | 120MG | Yes | No |
| 003 | CALAN | VERAPAMIL HYDROCHLORIDE | TABLET;ORAL | 40MG | No | No |
| 004 | CALAN | VERAPAMIL HYDROCHLORIDE | TABLET;ORAL | 160MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018817-001 | CALAN | VERAPAMIL HYDROCHLORIDE | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | |
| N018817-002 | CALAN | VERAPAMIL HYDROCHLORIDE | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | |
| N018817-003 | CALAN | VERAPAMIL HYDROCHLORIDE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | ||
| N018817-004 | CALAN | VERAPAMIL HYDROCHLORIDE | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 |
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| 2026-08 | N018817-001 | CALAN | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018817-002 | CALAN | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018817-003 | CALAN | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018817-004 | CALAN | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018817-001 | CALAN | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018817-002 | CALAN | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018817-003 | CALAN | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018817-004 | CALAN | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018817-001 | CALAN | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018817-002 | CALAN | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018817-003 | CALAN | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018817-004 | CALAN | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018817-001 | CALAN | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018817-002 | CALAN | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018817-003 | CALAN | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018817-004 | CALAN | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018817-001 | CALAN | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018817-002 | CALAN | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018817-003 | CALAN | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018817-004 | CALAN | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018817-001 | CALAN | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018817-002 | CALAN | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018817-003 | CALAN | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018817-004 | CALAN | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018817-001 | CALAN | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018817-002 | CALAN | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018817-003 | CALAN | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018817-004 | CALAN | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018817-001 | CALAN | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018817-002 | CALAN | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018817-003 | CALAN | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018817-004 | CALAN | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018817-001 | CALAN | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018817-002 | CALAN | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018817-003 | CALAN | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018817-004 | CALAN | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018817-001 | CALAN | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018817-002 | CALAN | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018817-003 | CALAN | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018817-004 | CALAN | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N018817-002 | AB | 1 | 74a2ff9319b5… |
| 2019-09-15 20:21 UTC | 2019-09 | N018817-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N018817-002 | 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 |
|---|---|---|---|---|---|---|
| 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.
NDC Listings For This Application#
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71184 | SUPPL | 2022-06-01 |
| 69376 | SUPPL | 2021-11-23 |
| 49801 | SUPPL | 2017-09-19 |
| 49760 | SUPPL | 2017-09-18 |
| 45235 | SUPPL | 2016-08-24 |
| 33613 | SUPPL | 2013-10-31 |
| 16060 | SUPPL | 2013-10-28 |
| 1095 | SUPPL | 2011-11-07 |
| 33612 | SUPPL | 2011-11-04 |
| 1094 | SUPPL | 2011-07-05 |
| 33611 | SUPPL | 2011-06-30 |
| 33610 | SUPPL | 2010-04-19 |
| 1093 | SUPPL | 2010-04-19 |
| 33609 | SUPPL | 2009-07-23 |
| 16059 | SUPPL | 2009-07-17 |