FdaApplication
ANDA 210647
Identifiers
- fda_app_no: ANDA210647
Properties
| Property | Value |
|---|---|
| applicant_name | ALKEM LABORATORIES LTD |
| application_type | ANDA |
| approval_date | 2020-07-14 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL |
1 product