Application 091442
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | SOLUTION/DROPS;OPHTHALMIC | 0.2%;EQ 0.5% BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-0589 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution | Brimonidine Tartrate and Timolol Maleate | Apotex Corp. | ANDA | Current |
| 60505-0589 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution | Brimonidine Tartrate and Timolol Maleate | Apotex Corp. | ANDA | Current |