Application 216343
- Type
- ANDA
- Sponsor
- AMNEAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TIMOLOL MALEATE | TIMOLOL MALEATE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | EQ 0.25% BASE | No | No |
| 002 | TIMOLOL MALEATE | TIMOLOL MALEATE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | EQ 0.5% BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78840 | ORIG | 2024-06-20 |