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| CALAN | VERAPAMIL HYDROCHLORIDE | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | |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| CALAN | VERAPAMIL HYDROCHLORIDE | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | |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| CALAN | VERAPAMIL HYDROCHLORIDE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 | ||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| CALAN | VERAPAMIL HYDROCHLORIDE | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1988-02-23 |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| 2026-08 | N018817-001 | CALAN | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 84e616aacf4f… | |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| 2026-08 | N018817-002 | CALAN | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-09-10 | 84e616aacf4f… | |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 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ed1e0c14-3571-43f9-88fc-5a4d2b598263 | 2022-03-12 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | c86084bc-33aa-eece-5a96-6c0dad2d1a32 | 2021-06-21 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | Gland Pharma Limited | eb3c66f6-581f-422b-9ca2-9b877b323a33 | 2020-10-19 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 2712ab16-122b-4f44-a687-e2cb3c04019e | 2020-04-09 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Baxter Healthcare Corporation | 03c5daf8-5399-4d89-a747-9a9d7667b6e4 | 2020-03-25 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Armas Pharmaceuticals Inc. | 2d595d9d-af88-474d-b622-d63d786f06a7 | 2020-01-08 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Armas Pharmaceuticals Inc. | 51597adb-bfb1-4611-b577-8989724fc3a4 | 2020-01-04 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | Proficient Rx LP | 19cb23bd-cc6d-45fc-a1fc-b4130ea460a6 | 2019-11-01 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | Proficient Rx LP | a6de732a-fe48-486d-bb05-0a9fff6f42d7 | 2019-10-01 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | Proficient Rx LP | 4ffa579e-1d85-4b3b-ae06-6a9334e0f9e1 | 2019-10-01 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | c635f442-2349-4820-877a-a42e5f0a44b5 | 2019-05-08 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | EXELA PHARMA SCIENCES, LLC | eff5e83b-f819-4a5b-9746-12bce328d7a7 | 2017-02-21 | Warnings, Adverse reactions | VERAPAMIL HYDROCHLORIDE |
| Verapamil Hydrochloride | VERAPAMIL HYDROCHLORIDE | EXELA PHARMA SCIENCES, LLC | 3318e357-0660-44f4-8170-91a51bd762fb | 2017-01-23 | 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 |