FdaApplication
ANDA 040504
Identifiers
- fda_app_no: ANDA040504
Properties
| Property | Value |
|---|---|
| applicant_name | ABLE LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2003-04-11 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY;RECTAL |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY;RECTAL |
2 products