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 |
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 |