Application 076649
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 3.125MG | No | No |
| 002 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 6.25MG | No | No |
| 003 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 12.5MG | No | No |
| 004 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 25MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 53808-0827 | Carvedilol | Carvedilol | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55111-252 | Carvedilol | Carvedilol | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-253 | Carvedilol | Carvedilol | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-254 | Carvedilol | Carvedilol | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-255 | Carvedilol | Carvedilol | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 68788-0253 | Carvedilol | Carvedilol | Preferred Pharmaceuticals, Inc | ANDA | Current |
| 68788-0254 | Carvedilol | Carvedilol | Preferred Pharmaceuticals, Inc | ANDA | Current |
| 68788-0999 | Carvedilol | Carvedilol | Preferred Pharmaceuticals, Inc | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31151 | ORIG | 2007-09-07 |