FdaApplication
ANDA 209924
Identifiers
- fda_app_no: ANDA209924
Properties
| Property | Value |
|---|---|
| applicant_name | ELITE LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2018-11-16 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;2.5MG | TABLET;ORAL |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET;ORAL |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;5MG | TABLET;ORAL |
4 products