Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Nitrofurazone Topical Solution (ANDA087081)
The FDA approved ANDA087081 for a 0.2% nitrofurazone topical solution submitted by Wendt; the product is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA085911 for Oxycodone 5/APAP 500 Oral Tablet
FDA approved ANDA085911 for an oral tablet containing 5 mg oxycodone and 500 mg acetaminophen, submitted by Bristol Myers Squibb; the product is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA077941 for Injectable Furosemide (10 mg/mL) by Apotex
The FDA has granted approval (ANDA077941) for Apotex's injectable furosemide 10 mg/mL, classified as a prescription product.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA077652 for Levofloxacin Oral Tablets
The FDA has approved ANDA077652 for levofloxacin tablets (250 mg, 500 mg, 750 mg) manufactured by Zydus Lifesciences and Viona Pharmaceuticals.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA077345 for Sertraline Hydrochloride Tablets (Heritage Pharma Avet)
The FDA has approved ANDA077345 submitted by Heritage Pharma Avet for oral sertraline hydrochloride tablets in 25 mg, 50 mg and 100 mg strengths. All listed products are currently marked discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Labeling Submissions for Loxapine Succinate (ANDA076762)
FDA has approved several labeling supplements for the discontinued oral capsule products of Loxapine Succinate under ANDA076762.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Mometasone Furoate Topical Ointment (ANDA076481)
FDA granted approval for ANDA076481, a prescription 0.1% mometasone furoate topical ointment manufactured by Encube Ethicals, Inc.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA078541 for Mometasone Furoate Cream
FDA approved application ANDA078541 for a 0.1% mometasone furoate topical cream by Glenmark Pharmaceuticals. Original approval in 2008 with later labeling updates; product now discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Lupin Losartan Potassium/Hydrochlorothiazide Combination (ANDA078245)
FDA has approved an ANDA for Lupin's prescription oral tablets combining losartan potassium and hydrochlorothiazide, available in multiple strengths.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA084581 for Hydralazine Tablet – IVAX Sub Teva
FDA approved ANDA084581 for a 100 mg oral tablet of Hydralazine Hydrochloride by IVAX Sub Teva Pharm on Sep 12 1975; the product is now discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Issues ANDA084080 for Promethazine Hydrochloride Tablet
FDA assigned ANDA084080 to TABLICAPS for an oral 12.5 mg promethazine hydrochloride tablet, now listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA081069 for Hydrocodeine Bitartrate and Acetaminophen Oral Capsule
The FDA approved ANDA081069 for an oral capsule containing 5 mg hydrocodeine bitartrate and 500 mg acetaminophen, sponsored by Mikart. The product is listed as discontinued.