FdaApplication
ANDA 200963
Identifiers
- fda_app_no: ANDA200963
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL PHARMACEUTICALS |
| application_type | ANDA |
| approval_date | 2015-08-26 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE | CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;5MG/5ML;6.25MG/5ML | SYRUP;ORAL |
1 product