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| CALAN | VERAPAMIL HYDROCHLORIDE | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | |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| CALAN | VERAPAMIL HYDROCHLORIDE | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | |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| CALAN | VERAPAMIL HYDROCHLORIDE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | ||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| CALAN | VERAPAMIL HYDROCHLORIDE | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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UTC | 2026-02 | N018817-001 | CALAN | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 011fe1cb6892… | |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UTC | 2026-02 | N018817-002 | CALAN | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 011fe1cb6892… | |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… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | 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 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | 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 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018817-003 | CALAN | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018817-004 | CALAN | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | 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 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | 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 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018817-003 | CALAN | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018817-004 | CALAN | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | d06236e962d9… |
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 | HF Acquisition Co LLC, DBA HealthFirst | df79ee3a-f0ed-1cc7-e053-2995a90af97f | 2026-07-23 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | Lifestar Pharma LLC | df77b8d1-1d2b-4fea-a1e9-153bd25008a6 | 2026-07-10 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Hospira, Inc. | 1c993365-1b62-4524-e781-d307f28f63bc | 2026-07-09 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | REMEDYREPACK INC. | ce9ab27a-e03b-4e40-a0e0-b586cd75dead | 2026-06-29 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Somerset Therapeutics, LLC | 50131bbc-ad43-4708-946f-e4000828137c | 2026-06-24 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Safecor Health LLC | bf7b5037-7355-4788-b17b-323c18a5aee7 | 2026-06-23 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Henry Schein, Inc. | 4f6ae43f-c28a-4eac-9b19-8b5d0c12dfaa | 2026-06-19 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | REMEDYREPACK INC. | 5dc5f087-c8da-4ed0-b532-ae44508958aa | 2026-06-01 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Nivagen Pharmaceuticals, Inc. | e36e485f-fbed-4e30-9a63-984931f2e54e | 2026-05-13 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 4dcc46d8-76b0-fbd4-e063-6294a90ad9e6 | 2026-05-05 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Hospira, Inc. | 70057a53-ca29-4848-ab3d-5e691e2a14a3 | 2026-04-29 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | Zydus Lifesciences Limited | 051392d3-8ec1-450c-8c38-791d4ef1a2db | 2026-04-09 | VERAPAMIL HYDROCHLORIDE | |
| Verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | e19ab8d8-dae5-489d-9805-7e7407bea06d | 2026-04-06 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 4dcb137e-b01a-eb3a-e063-6294a90aaecc | 2026-03-24 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Bryant Ranch Prepack | 1de6ad5c-942e-4381-b01f-e5e63bbf72ef | 2026-03-10 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | A-S Medication Solutions | e07b3574-9259-4f64-a9ae-f4e0e64800b6 | 2026-03-07 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Cadila Pharmaceuticals Limited | 5501208c-aa2b-47aa-89f7-87f4d4a73fd0 | 2026-02-09 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | AvKARE | a32f346e-71cf-cc11-e053-2a95a90ae88c | 2026-01-15 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| 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 |
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 |