FdaApplication
ANDA 078503
Identifiers
- fda_app_no: ANDA078503
Properties
| Property | Value |
|---|---|
| applicant_name | OSMOTICA PHARMACEUTICAL US LLC |
| application_type | ANDA |
| approval_date | 2009-02-04 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL |
3 products