FdaApplication
ANDA 209385
Identifiers
- fda_app_no: ANDA209385
Properties
| Property | Value |
|---|---|
| applicant_name | ELITE LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2018-07-02 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL |
3 products