FdaApplication
ANDA 040649
Identifiers
- fda_app_no: ANDA040649
Properties
| Property | Value |
|---|---|
| applicant_name | PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA |
| application_type | ANDA |
| approval_date | 2006-02-14 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROMETHAZINE DM | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE | 15MG/5ML;6.25MG/5ML | SYRUP;ORAL |
1 product