FdaApplication
ANDA 219161
Identifiers
- fda_app_no: ANDA219161
Properties
| Property | Value |
|---|---|
| applicant_name | NOVITIUM PHARMA LLC |
| application_type | ANDA |
| approval_date | 2025-12-10 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 40MG/PACKET;1.68GM/PACKET | FOR SUSPENSION;ORAL |
| OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 20MG/PACKET;1.68GM/PACKET | FOR SUSPENSION;ORAL |
2 products