Regulatorische Updates

Watson Labs' diphenhydramine hydrochloride injectable (product 001) is recorded by the FDA under ANDA083533 as discontinued and not a reference drug.

The FDA approved ANDA 076815 submitted by Parenta Pharms for a 5 mg/mL injectable diazepam product, currently listed as discontinued.

FDA granted priority approval to OSTEOSCAN, a technetium‑99m etidronate injectable, on Sep 28 1973; later supplemental filings updated labeling, manufacturing and efficacy. Product now discontinued.

FDA has approved Hospira's aztreonam injectable (1 g and 2 g vials) for intramuscular and intravenous use under ANDA206517.

The FDA has approved application ANDA205336 for a prescription diphenhydramine hydrochloride injectable (50 mg/mL) product marketed by Avet Lifesciences for IM and IV use.

FDA granted approval for Hikma's deferoxamine mesylate injectable products (ANDA078086), available in 500 mg and 2 g vials, both listed as discontinued.

The FDA has approved Sun Pharmaceutical's epoprostenol injectable (ANDA210473), covering 0.5 mg and 1.5 mg vial strengths for intravenous use.

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

The FDA’s NDA007504 approval for ACTHAR injectable (25 UNITS/VIAL and 40 UNITS/VIAL) by Sanofi Aventis includes multiple priority labeling supplements, though the products are listed as discontinued.

FDA approved NDA017780 for PHARM SPEC's Heparin Sodium injectable products, listing five strengths now marked discontinued.

The FDA has approved Hospira’s Metoprolol Tartrate injectable (ANDA078085), an intravenous prescription drug with a 1 mg/mL strength.

FDA’s ANDA 076889 lists two injectable fluconazole products from Mylan Labs, both marked as discontinued.