Regulatory Updates
Sep 8, 2026•1 min read
FDA ANDA084259 for Methocarbamol 500 mg Oral Tablet (Mylan) – Discontinued
The FDA’s ANDA084259 for a 500 mg methocarbamol oral tablet, sponsored by Mylan, is listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA090265 for Hydrocodone/Acetaminophen Tablets
The FDA's ANDA090265, submitted by CARACO, received approval on Dec 23, 2008 for three oral hydrocodone bitartrate/acetaminophen tablet strengths, now listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
Quad Pharms Isoniazid Injection (100 mg/mL) Listed as Discontinued in FDA ANDA089816
FDA records show Quad Pharms' Isoniazid injectable (100 mg/mL) under ANDA089816 is marked as discontinued.
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Regulatory Updates
Sep 8, 2026•1 min read
Hydroxyzine Hydrochloride 50 mg Tablet Discontinued – FDA Submission History
FDA records indicate the oral Hydroxyzine Hydrochloride 50 mg tablet (product 001) is discontinued, with multiple manufacturing and labeling submissions approved between 1989 and 2016.
Regulatory Updates
Sep 8, 2026•1 min read
CENCI Announces Discontinuation of PROMETHAZINE Oral Syrup (ANDA089013)
CENCI's PROMETHAZINE oral syrup (product 001) is listed as discontinued in the FDA ANDA089013 filing.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves KVK TECH Betaxolol Hydrochloride Oral Tablets (ANDA078962)
The FDA has approved ANDA 078962 for Betaxolol Hydrochloride oral tablets, 10 mg and 20 mg, manufactured by KVK TECH. Both products are prescription‑only.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves SUN PHARM INDS INC ANDA078654 for Clonazepam ODTs
FDA has approved ANDA078654 submitted by SUN PHARM INDS INC for clonazepam orally disintegrating tablets across several strengths; all listed products are currently discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves Labeling Updates for Chartwell Rx’s Discontinued Desloratadine Tablet (ANDA078364)
The FDA has granted several labeling approvals for Chartwell Rx’s desloratadine 5 mg oral tablet (ANDA078364), though the product is listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves CALCITRIOL Injection (ANDA078066)
FDA granted approval for CALCITRIOL injectable products (ANDA078066) from LONG GROVE PHARMS, including a prescription 0.001 mg/mL product and a discontinued 0.002 mg/mL version.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA077766 for Simvastatin Generic Tablets
The FDA granted approval for Chartwell Rx's ANDA077766, covering five discontinued Simvastatin tablet strengths and subsequent labeling updates.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves Labeling for Teva’s Discontinued Ramipril Capsules (ANDA 077470)
Teva Pharmaceuticals’ oral ramipril capsule products (1.25‑10 mg) were listed as discontinued, with multiple FDA labeling supplements approved between 2008 and 2014.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA076589 for FLUMAZENIL Injectable Products
FDA approved ANDA076589 submitted by Dr Reddys, covering two injectable FLUMAZENIL products, both listed with discontinued marketing status.