FdaApplication
ANDA 077127
Identifiers
- fda_app_no: ANDA077127
Properties
| Property | Value |
|---|---|
| applicant_name | OSMOTICA PHARMACEUTICAL US LLC |
| application_type | ANDA |
| approval_date | 2005-11-21 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL |
| NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL |
| NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL |
3 products