Application 090233
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | INJECTABLE;INJECTION | 1MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 14789-300 | Benztropine Mesylate | BENZTROPINE MESYLATE | Nexus Pharmaceuticals Inc | ANDA | Current |
| 63323-970 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-970 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 22707 | ORIG | 2012-04-25 |