Regulatory Updates

The FDA approved the original ANDA for Glenmark's Mometasone Furoate topical ointment on May 28, 2008, and later granted labeling supplements in 2015 and 2024; the product is now discontinued.

FDA has approved labeling for oral Olmesartan Medoxomil tablets (5 mg, 20 mg, 40 mg) under ANDA 078276 submitted by Rising; the products are listed as discontinued.

The FDA approved Sun Pharm Industries’ ANDA 077975 for oral disintegrating tablets of Donepezil Hydrochloride (5 mg and 10 mg), though both products are listed as discontinued.

FDA has approved ANDA 084307 for Hikma Pharmaceuticals' generic phenytoin sodium injectable, available for intramuscular and intravenous use with multiple NDC listings.

Sandoz's generic ophthalmic solution containing 0.05% epinastine hydrochloride has been granted tentative approval by the FDA under ANDA090950.

The FDA lists PROPOXYPHENE COMPOUND-65 oral capsules as discontinued, detailing its active ingredients and a series of manufacturing and labeling submissions from 1976 to 1995.

The FDA’s ANDA080195 filing shows that MILES’ injectable potassium chloride products (1–4 mEq/mL) are listed as discontinued.

The National Assembly has activated a task force to expedite amendment of 27 laws deemed unconstitutional or inconsistent with the Constitution, following directives from Speaker Jo Jeong-sik.

FDA records an ANDA (ANDA083706) for Mylan's oral propantheline bromide 15 mg tablet, currently marked as discontinued.

The FDA granted approval for NDA 017830, authorizing the prescription oral tablet Lodosyn (carbidopa) from Bausch Health US and Oceanside Pharmaceuticals.

The FDA approved ANDA080741 for BEL MAR's Testosterone Propionate injectable, a discontinued product, on Dec 3, 1973.

The FDA has approved Sandoz’s over‑the‑counter children’s cetirizine hydrochloride chewable tablets (5 mg and 10 mg) under ANDA 078692.