FdaApplication
ANDA 040454
Identifiers
- fda_app_no: ANDA040454
Properties
| Property | Value |
|---|---|
| applicant_name | TEVA PHARMACEUTICALS USA |
| application_type | ANDA |
| approval_date | 2002-08-22 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
2 products