Application 077346
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 6.25MG | No | No |
| 002 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 12.5MG | No | No |
| 003 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 25MG | No | No |
| 004 | CARVEDILOL | CARVEDILOL | TABLET;ORAL | 3.125MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 57664-242 | Carvedilol | Carvedilol | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-244 | Carvedilol | Carvedilol | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-245 | Carvedilol | Carvedilol | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-247 | Carvedilol | Carvedilol | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 39528 | ORIG | 2007-09-07 |
| 31225 | ORIG | 2007-09-07 |