Application 078479
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | SOLUTION/DROPS;OPHTHALMIC | 0.15% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-0564 | Brimonidine Tartrate | brimonidine tartrate | Apotex Corp. | ANDA | Current |
| 60505-0564 | Brimonidine Tartrate | brimonidine tartrate | Apotex Corp. | ANDA | Current |
| 60505-0564 | Brimonidine Tartrate | brimonidine tartrate | Apotex Corp. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 70072 | ORIG | 2022-02-04 |