Application 212942
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| 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 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62332-545 | Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% | Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-545 | Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% | Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-545 | Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% | Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-546 | Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% | Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-546 | Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% | Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-546 | Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% | Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% | Alembic Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 65505 | ORIG | 2020-12-07 |