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The FDA has approved application ANDA216216 for METOLAZONE oral tablets in 2.5 mg, 5 mg, and 10 mg strengths, sponsored by NE RX Pharma.

The FDA approved Lupin’s injectable DOXERCALCIFEROL (4 mcg/2 ml) under ANDA210801; the product is listed as discontinued.

The FDA approved STEGLATRO, an oral ertugliflozin tablet (5 mg and 15 mg) from Merck Sharp & Dohme, NDA209803.

FDA approved ANDA076589 submitted by Dr Reddys, covering two injectable FLUMAZENIL products, both listed with discontinued marketing status.

The FDA has approved several labeling supplement submissions for the discontinued oral solution Levetiracetam (100 mg/mL) spanning from 2011 to 2024.

Unicycive is optimistic its third‑party manufacturing facility can meet FDA standards to support an approval, CEO Shalabh Gupta, M.D., said.

The FDA lists APRESAZIDE oral capsules (hydralazine HCl 25 mg / hydrochlorothiazide 25 mg) as discontinued, with a series of approved original and supplemental submissions from 1976 to 1998.

The FDA has approved ANDA078965 for a prescription oral tablet combining norethindrone, ethinyl estradiol, and ferrous fumarate, submitted by BARR.

FDA approved ANDA087274 for two hydroxyzine hydrochloride injectable products from Watson Labs; both are now listed as discontinued.

The Pharmaceuticals and Medical Devices Agency (PMDA) has posted an updated list of approved medical devices covering April 2004 to September 2025.