Application 205294
- Type
- ANDA
- Sponsor
- FDC LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DORZOLAMIDE HYDROCHLORIDE | DORZOLAMIDE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | EQ 2% BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55545-1008 | Dorzolamide hydrochloride | Dorzolamide hydrochloride | FDC Limited | ANDA | Current |
| 69315-304 | Dorzolamide hydrochloride | Dorzolamide hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-304 | Dorzolamide hydrochloride | Dorzolamide hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-304 | Dorzolamide hydrochloride | Dorzolamide hydrochloride | Leading Pharma, LLC | ANDA | Current |