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| CALAN | VERAPAMIL HYDROCHLORIDE | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | |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| CALAN | VERAPAMIL HYDROCHLORIDE | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | |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| CALAN | VERAPAMIL HYDROCHLORIDE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | ||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| CALAN | VERAPAMIL HYDROCHLORIDE | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 |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| 2026-08 | N018817-001 | CALAN | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 84e616aacf4f… | |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| 2026-08 | N018817-002 | CALAN | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 84e616aacf4f… | |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 | 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.
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 |