Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves Multiple Risperidone Tablet Strengths Under ANDA 078871
FDA has approved six oral tablet strengths of risperidone (0.25 mg to 4 mg) as prescription products, with labeling updates from 2008 to 2023.
Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA 078567 for Mylan’s Ciclopirox 8% Topical Solution
The FDA issued an approval letter for Mylan Pharm Inc.’s topical ciclopirox 8% solution (ANDA 078567), though the product is listed as discontinued.
Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA076786 for Donepezil Hydrochloride Tablets – Marketing Status Discontinued
SUN PHARM INDS LTD's ANDA076786 for oral Donepezil Hydrochloride tablets (5 mg and 10 mg) has been approved by the FDA, with both products listed as discontinued.
Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA 076504 for Fluticasone Propionate Nasal Spray
The FDA has approved ANDA 076504 for a prescription fluticasone propionate nasal spray, manufactured by Hikma Pharmaceuticals and Golden State Medical Supply.
Regulatory Updates
Sep 27, 2026•1 min read
Mallinckrodt Inc. Original ANDA 078273 Approved by FDA
Mallinckrodt Inc. received FDA approval for its original Abbreviated New Drug Application (ANDA) 078273 on September 19, 2007.
Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA 077973 for Bicalutamide 50 mg Tablet – Synthon Pharm
FDA approves ANDA 077973 for Synthon Pharm’s 50 mg oral bicalutamide tablet; labeling approved in 2009 and manufacturing in 2011.
Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves Padagis Ciclopirox Olamine Suspension (ANDA077676)
FDA grants approval for ANDA077676, a prescription ciclopirox olamine 0.77% topical suspension from Padagis Israel Pharmaceuticals.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Manufacturing Supplements for Sandoz Orphenadrine Citrate ER Tablet (ANDA 085046)
The FDA has approved several manufacturing (CMC) supplement submissions for Sandoz’s Orphenadrine Citrate extended‑release tablet (ANDA 085046), which is currently listed as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Marks PANRAY's THEOLIXIR Oral Elixir as Discontinued (ANDA084559)
The FDA’s ANDA084559 filing shows PANRAY’s oral elixir THEOLIXIR, containing THEOPHYLLINE 80MG/15ML, is listed as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA090137 for Sandoz Irinotecan Hydrochloride Injection
FDA approved Sandoz's ANDA090137 covering two Irinotecan Hydrochloride injectable products, both listed with discontinued marketing status.
1
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves AstraZeneca ISOETHARINE Inhalation (ANDA089615)
The FDA approved ANDA089615 for ISOETHARINE HYDROCHLORIDE inhalation solution (0.125%) by AstraZeneca. The product is listed as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA079164 for Flecainide Acetate Tablets by Chartwell RX
The FDA approved the abbreviated new drug application ANDA079164 for Flecainide Acetate tablets (50 mg, 100 mg, 150 mg) from Chartwell RX, though the products are currently listed as discontinued.