FdaApplication
ANDA 218264
Identifiers
- fda_app_no: ANDA218264
Properties
| Property | Value |
|---|---|
| applicant_name | HETERO LABS LTD UNIT III |
| application_type | ANDA |
| approval_date | 2026-03-12 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE | 15MG/5ML;6.25MG/5ML | SYRUP;ORAL |
1 product