Regulatory Updates
Sep 23, 2026•1 min read
FDA Approves Labeling Supplements for Discontinued Divalproex Sodium Delayed‑Release Tablets
The FDA records show that three discontinued oral delayed‑release tablet products of Divalproex Sodium (125 mg, 250 mg, 500 mg) received approved labeling supplemental submissions.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA 086822)
The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor SoloPak as discontinued under ANDA 086822.
Regulatory Updates
Sep 23, 2026•1 min read
SK Biopharm Maintains Development of Epilepsy Candidate BHV‑7000 Amid FDA Partial Hold
SK Biopharm keeps its epilepsy drug BHV‑7000 development despite an FDA partial clinical hold, while negotiating a final deal with Biohaven.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Discontinues Chlordiazepoxide Hydrochloride ANDA084700
The FDA has listed the ANDA084700 application for Chlordiazepoxide Hydrochloride 10 mg oral capsules as discontinued. Sponsor Roxane filed the original ANDA in 1976.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Multiple Supplemental Applications for Discontinued Chlorothiazide Tablets (ANDA 084217)
The FDA record for ANDA 084217 lists two discontinued oral chlorothiazide tablets (500 mg and 250 mg) and a series of approved supplemental submissions covering manufacturing, labeling and bioequivalence.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approval History for Discontinued Ophthalmic Product Naphazoline Hydrochloride
The FDA records show original approval in 1974 and multiple supplemental approvals for the ophthalmic solution Naphazoline Hydrochloride, now listed as discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Ethosuximide Oral Syrup (ANDA 081306)
The FDA has approved the oral syrup formulation of ethosuximide (250 mg/5 ml) under ANDA 081306, with multiple manufacturing and labeling submissions listed.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA 080630 for Cortisone Acetate 25 mg Tablet
The FDA has approved ANDA080630 for a 25 mg oral tablet of cortisone acetate, submitted by IVAX Sub Teva Pharm, with approval dated Jan 3 1972.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Lists Discontinued Thioridazine Hydrochloride Tablet (ANDA088660) by West Ward
The FDA database shows an ANDA (ANDA088660) for an oral tablet of thioridazine hydrochloride 25 mg submitted by West Ward, currently marked as discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Manufacturing Submission for Mylan’s Thioridazine Hydrochloride Tablet (ANDA088332)
The FDA has approved Mylan’s supplemental application (ANDA088332) for a 10 mg oral tablet of thioridazine hydrochloride, though the product is listed as discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA088010 for Chlordiazepoxide Hydrochloride Capsule
FDA granted approval (status AP) for VANGARD's ANDA088010 covering a 10 mg oral capsule of chlordiazepoxide hydrochloride, listed as discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA 078338 for Clotrimazole 1% Topical Cream
The FDA has approved ANDA 078338 for a prescription 1% clotrimazole topical cream marketed by Fougera Pharmas.