USFDA8 Aug 2025, 10:40 am
Marksans Pharma Inc. Receives USFDA Approval for Omeprazole Delayed-Release Tablets, 20 mg (OTC)
AI Summary
Marksans Pharma Limited announces the final approval of its wholly owned subsidiary Marksans Pharma Inc.’s Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-Release Tablets, 20 mg (OTC). The product is bioequivalent to the reference listed drug (RLD), Prilosec Delayed-Release Tablets, 20 mg (OTC), of AstraZeneca Pharmaceuticals LP. Omeprazole is used to treat heartburn and certain other conditions caused by too much acid in the stomach.
Key Highlights
- Marksans Pharma Inc. receives USFDA approval for Omeprazole Delayed-Release Tablets, 20 mg (OTC)
- Product is bioequivalent to the reference listed drug (RLD), Prilosec Delayed-Release Tablets, 20 mg (OTC)
- Omeprazole is used to treat heartburn and certain other conditions caused by too much acid in the stomach