Application 215520
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68083-490 | Dorzolamide Hydrochloride and Timolol Maleate | Dorzolamide Hydrochloride and Timolol Maleate | Gland Pharma Limited | ANDA | Current |