Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA077302 for Actavis Extended‑Release Amphetamine Combination Capsules
The FDA approved ANDA077302 for Actavis Pharma’s oral extended‑release capsules containing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate in multiple strengths.
Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves Bausch & Lomb Ophthalmic Diclofenac Sodium 0.1% Solution (ANDA078792)
The FDA has approved Bausch & Lomb’s ophthalmic diclofenac sodium 0.1% solution (ANDA078792) for prescription use, confirming its safety and efficacy.
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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 25, 2026•1 min read
FDA Approves DIVALPROEX SODIUM (ANDA078853)
FDA grants approval for DIVALPROEX SODIUM tablets (ANDA078853) by Bionpharma Inc., with oral delayed‑release 125 mg, 250 mg and 500 mg equivalents.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA 076768 for Alendronate Sodium Tablets
The FDA has granted approval for an Abbreviated New Drug Application (ANDA) 076768 covering multiple strengths of alendronate sodium tablets, manufactured by Exelan Pharmaceuticals and Cipla USA.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Chartwell Allopurinol Generic (ANDA077353)
FDA has approved Chartwell RX's generic allopurinol tablets (100 mg and 300 mg) under ANDA 077353, confirming prescription status and labeling updates.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves AMMONIUM LACTATE Topical Lotion (ANDA 076216)
The FDA has approved a prescription topical lotion containing 12% ammonium lactate, submitted under ANDA 076216 by Sun Pharma Canada.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves ANDA217961 for CARBIDOPA 25mg Oral Tablet
The FDA has approved ANDA217961 for CARBIDOPA 25 mg oral tablets, a prescription product submitted by Regcon Holdings.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves Bionpharma’s Nicardipine Hydrochloride Capsules (ANDA217555)
The FDA granted approval (AP) for Bionpharma Inc.’s nicardipine hydrochloride oral capsules, 20 mg and 30 mg strengths, under application ANDA217555.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves ANDA209591 for Amlodipine and Olmesartan Combination Tablet
The FDA has approved ANDA209591 for a prescription oral tablet combining amlodipine besylate and olmesartan medoxomil, sponsored by Hetero Labs.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Grants ANDA209932 Approval for Magnesium Sulfate Injection (Pharmobedient)
Pharmobedient received FDA approval (ANDA209932) for its magnesium sulfate 5% injection in a plastic container, designated as a prescription product.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves Nitrogen Inhalation Drug (NDA212315) for Prescription Use
The FDA has approved the prescription inhalation product NITROGEN, NF (NDA212315), a medical gas for respiratory use, sponsored by Universal Industrial Gases, Inc.