Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA078594 for Topical Ciclopirox Shampoo
The FDA has approved ANDA078594 for a 1% ciclopirox prescription shampoo, a topical treatment manufactured by Padagis US.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves CILOSTAZOL Tablets (ANDA077831)
FDA has approved Chartwell Rx's ANDA077831 for oral CILOSTAZOL tablets in 50 mg and 100 mg strengths, with labeling updates approved in 2016.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Grants ANDA Approval for Amcinonide Topical Lotion (ANDA076329)
Solubiomix received FDA approval for ANDA 076329 for a prescription topical lotion containing 0.1% amcinonide.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA078670 for Pioglitazone Hydrochloride Tablets
FDA has approved ANDA078670 submitted by Aiping Pharm Inc for prescription pioglitazone hydrochloride tablets in 15 mg, 30 mg, and 45 mg strengths.
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Regulatory Updates
Aug 30, 2026•1 min read
Fougéra Pharms Receives FDA Approval for Alclometasone Dipropionate Topical Ointment (ANDA 076884)
The FDA approved an ANDA for alclometasone dipropionate 0.05% topical ointment submitted by Fougéra Pharms. Original approval was granted in July 2005 with a labeling supplement in August 2015.
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Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Hikma Granisetron Hydrochloride Injection (ANDA077177)
FDA has approved Hikma's Granisetron Hydrochloride injectable (ANDA077177) with labeling updates in 2014 and 2022, confirming its prescription status.
Regulatory Updates
Aug 26, 2026•1 min read
FDA Grants ANDA077797 Approval for Cycbenzaprine Hydrochloride Tablets
The FDA approved ANDA077797 for prescription oral tablets of Cycbenzaprine Hydrochloride, 5 mg and 10 mg, manufactured by Solco Healthcare U.S., LLC and sponsored by Prinston Inc.
Regulatory Updates
Aug 25, 2026•1 min read
FDA Approves ANDA078965 for Norethindrone/Ethinyl Estradiol/Ferrous Fumarate Tablet
The FDA has approved ANDA078965 for a prescription oral tablet combining norethindrone, ethinyl estradiol, and ferrous fumarate, submitted by BARR.