FdaApplication
NDA 008306
Identifiers
- fda_app_no: NDA008306
Properties
| Property | Value |
|---|---|
| applicant_name | ANI PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 1984-04-02 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PHENERGAN VC W/ CODEINE | CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL |
| PHENERGAN W/ CODEINE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL |
2 products