Application 213099
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | SOLUTION/DROPS;OPHTHALMIC | EQ 2% BASE;EQ 0.5% BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62332-553 | Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution | Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution | Alembic Pharmaceuticals Inc. | ANDA | Current |