FdaApplication
ANDA 212418
Identifiers
- fda_app_no: ANDA212418
Properties
| Property | Value |
|---|---|
| applicant_name | ELITE LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2019-09-10 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL |
3 products