Application 207338
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.1MG BASE | No | No |
| 002 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.2MG BASE | No | No |
| 003 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.3MG BASE | No | No |
| 004 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.4MG BASE | No | No |
| 005 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.6MG BASE | No | No |
| 006 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;SUBLINGUAL | EQ 0.8MG BASE | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76276 | ORIG | 2023-11-03 |
| 50731 | ORIG | 2017-12-18 |