Application 215624
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ATROPINE SULFATE | ATROPINE SULFATE | SOLUTION/DROPS;OPHTHALMIC | 1% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-6226 | Atropine | Atropine Sulfate | Apotrex Corp. | ANDA | Current |
| 60505-6226 | Atropine | Atropine Sulfate | Apotrex Corp. | ANDA | Current |
| 60505-6226 | Atropine | Atropine Sulfate | Apotex Corp. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69694 | ORIG | 2021-12-20 |