Application 091087
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE | SOLUTION; OPHTHALMIC | 0.2%; 0.5% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-7186 | Brimonidine Tartrate and Timolol Maleate | Brimonidine Tartrate and Timolol Maleate | Sandoz Inc | ANDA | Current |
| 0781-7186 | Brimonidine Tartrate and Timolol Maleate | Brimonidine Tartrate and Timolol Maleate | Sandoz Inc | ANDA | Current |
| 0781-7186 | Brimonidine Tartrate and Timolol Maleate | Brimonidine Tartrate and Timolol Maleate | Sandoz Inc | ANDA | Current |
| 0781-7186 | Brimonidine Tartrate and Timolol Maleate | Brimonidine Tartrate and Timolol Maleate | Sandoz Inc | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71900 | ORIG | 2022-08-26 |