Application 206329
- Type
- ANDA
- Sponsor
- MAYNE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.1MG BASE | No | No |
| 002 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.2MG BASE | No | No |
| 003 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.3MG BASE | No | No |
| 004 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.4MG BASE | No | No |
| 005 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.6MG BASE | No | No |
| 006 | FENTANYL CITRATE | FENTANYL CITRATE | TABLET;BUCCAL, SUBLINGUAL | EQ 0.8MG BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76277 | ORIG | 2023-11-03 |