FdaApplication
ANDA 091070
Identifiers
- fda_app_no: ANDA091070
Properties
| Property | Value |
|---|---|
| applicant_name | ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC |
| application_type | ANDA |
| approval_date | 2015-08-31 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 60MG;1.2GM | TABLET, EXTENDED RELEASE;ORAL |
| GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | 30MG;600MG | TABLET, EXTENDED RELEASE;ORAL |
2 products