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Application 213718
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BREXPIPRAZOLE | BREXPIPRAZOLE | TABLET; ORAL | 0.25MG | No | No |
| 002 | BREXPIPRAZOLE | BREXPIPRAZOLE | TABLET;ORAL | 0.5MG | No | No |
| 003 | BREXPIPRAZOLE | BREXPIPRAZOLE | TABLET;ORAL | 1MG | No | No |
| 004 | BREXPIPRAZOLE | BREXPIPRAZOLE | TABLET;ORAL | 2MG | No | No |
| 005 | BREXPIPRAZOLE | BREXPIPRAZOLE | TABLET;ORAL | 3MG | No | No |
| 006 | BREXPIPRAZOLE | BREXPIPRAZOLE | TABLET;ORAL | 4MG | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 68530 | ORIG | 2021-09-02 |