Marksans Pharma Limited has announced the final approval of the company’s wholly owned subsidiary, Marksans Pharma Inc., for its Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-Release Tablets, 20 mg, as an over-the-counter (OTC) product.
In its statement, the company said, “Marksans Pharma Limited hereby announces the final approval of the Company’s wholly owned subsidiary Marksans Pharma Inc.’s Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-Release Tablets, 20 mg (OTC).”
The product, according to the filing, “is bioequivalent to the reference listed drug (RLD), Prilosec Delayed-Release Tablets, 20 mg (OTC), of AstraZeneca Pharmaceuticals LP, NDA – 021229.”
Marksans Pharma also noted, “Omeprazole is used to treat heartburn and certain other conditions caused by too much acid in the stomach.” This includes conditions where reducing stomach acid can help relieve discomfort and prevent further complications.
