FdaApplication
ANDA 075785
Identifiers
- fda_app_no: ANDA075785
Properties
| Property | Value |
|---|---|
| applicant_name | IMPAX LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2007-10-22 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS;ORAL |
| OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS;ORAL |
| OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS;ORAL |
3 products