FdaApplication
ANDA 085363
Identifiers
- fda_app_no: ANDA085363
Properties
| Property | Value |
|---|---|
| applicant_name | KV PHARMACEUTICAL CO |
| application_type | ANDA |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 325MG;45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
1 product