Regulatory Updates
Sep 13, 2026•1 min read
FDA Lists Diphenhydramine Hydrochloride Injection (ANDA083533) as Discontinued
Watson Labs' diphenhydramine hydrochloride injectable (product 001) is recorded by the FDA under ANDA083533 as discontinued and not a reference drug.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA 076815 for Diazepam Injectable
The FDA approved ANDA 076815 submitted by Parenta Pharms for a 5 mg/mL injectable diazepam product, currently listed as discontinued.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves OSTEOSCAN (NDA 017454) as Radiopharmaceutical Injection
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.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA206517 for Aztreonam Injectable Products
FDA has approved Hospira's aztreonam injectable (1 g and 2 g vials) for intramuscular and intravenous use under ANDA206517.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA205336 for Diphenhydramine Hydrochloride Injectable
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.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Hikma Deferoxamine Mesylate Injectable (ANDA078086)
FDA granted approval for Hikma's deferoxamine mesylate injectable products (ANDA078086), available in 500 mg and 2 g vials, both listed as discontinued.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Sun Pharma Epoprostenol Injection (ANDA210473)
The FDA has approved Sun Pharmaceutical's epoprostenol injectable (ANDA210473), covering 0.5 mg and 1.5 mg vial strengths for intravenous use.
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Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Lupin’s DOXERCALCIFEROL Injection (ANDA210801)
The FDA approved Lupin’s injectable DOXERCALCIFEROL (4 mcg/2 ml) under ANDA210801; the product is listed as discontinued.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ACTHAR Injectable (NDA007504)
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.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves NDA017780 for PHARM SPEC Heparin Sodium Injection
FDA approved NDA017780 for PHARM SPEC's Heparin Sodium injectable products, listing five strengths now marked discontinued.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Grants Approval for Metoprolol Tartrate Injectable (ANDA078085) by Hospira
The FDA has approved Hospira’s Metoprolol Tartrate injectable (ANDA078085), an intravenous prescription drug with a 1 mg/mL strength.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Lists Two Discontinued Fluconazole Injection Products Under ANDA 076889
FDA’s ANDA 076889 lists two injectable fluconazole products from Mylan Labs, both marked as discontinued.