Application 077474
- Type
- ANDA
- Sponsor
- CHARTWELL MOLECULAR
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 |
|---|
| 69097-263 | CARVEDILOL | carvedilol | Cipla USA Inc. | ANDA | Current |
| 69097-264 | CARVEDILOL | carvedilol | Cipla USA Inc. | ANDA | Current |
| 69097-265 | CARVEDILOL | carvedilol | Cipla USA Inc. | ANDA | Current |
| 69097-266 | CARVEDILOL | carvedilol | Cipla USA Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9051 | ORIG | 2007-09-07 |