Application 206952
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | CAPSULE, EXTENDED RELEASE; ORAL | 10MG | No | No |
| 005 | HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | 40MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 45819 | APPL | 2016-11-04 |