Application 204717
- Type
- ANDA
- Sponsor
- IMPAX LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG | No | No |
| 002 | CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | CAPSULE, EXTENDED RELEASE;ORAL | 20MG | No | No |
| 003 | CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | CAPSULE, EXTENDED RELEASE;ORAL | 40MG | No | No |
| 004 | CARVEDILOL PHOSPHATE | CARVEDILOL PHOSPHATE | CAPSULE, EXTENDED RELEASE;ORAL | 80MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 51023 | ORIG | 2018-01-10 |