FdaApplication
ANDA 090180
Identifiers
- fda_app_no: ANDA090180
Properties
| Property | Value |
|---|---|
| applicant_name | CHARTWELL RX SCIENCES LLC |
| application_type | ANDA |
| approval_date | 2010-03-17 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;6.25MG/5ML | SYRUP;ORAL |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 10MG;5ML | SYRUP;ORAL |
2 products