Regulatory Updates
Aug 26, 2026•1 min read
FDA Approves ANDA078101 for Teva’s Levetiracetam Oral Tablets
The FDA has approved labeling submissions for Teva Pharm’s discontinued levetiracetam tablets (250 mg, 500 mg, 750 mg, 1 g) under ANDA078101.
Regulatory Updates
Aug 26, 2026•1 min read
FDA Lists ANDA085199 for Discontinued Phendimetrazine Tartrate Oral Tablet
FDA’s database shows ANDA085199 for a discontinued 35 mg oral tablet of Phendimetrazine Tartrate submitted by PVT FORM.
Regulatory Updates
Aug 26, 2026•1 min read
FDA Approves Multiple Submissions for APRESAZIDE (ANDA 084735)
The FDA lists APRESAZIDE oral capsules (hydralazine HCl 25 mg / hydrochlorothiazide 25 mg) as discontinued, with a series of approved original and supplemental submissions from 1976 to 1998.
Regulatory Updates
Aug 25, 2026•1 min read
FDA Approves ANDA080094 for TRIPLE SULFOID Oral Tablet (Discontinued)
The FDA approved ANDA080094 for the oral tablet TRIPLE SULFOID, containing trisulfapyrimidines, sulfamerazine, and sulfamethazine, though the product is listed as discontinued.
Regulatory Updates
Aug 25, 2026•1 min read
FDA Approves ANDA078965 for Norethindrone/Ethinyl Estradiol/Ferrous Fumarate Tablet
The FDA has approved ANDA078965 for a prescription oral tablet combining norethindrone, ethinyl estradiol, and ferrous fumarate, submitted by BARR.
Regulatory Updates
Aug 25, 2026•1 min read
FDA Approves ANDA087274 for Hydroxyzine Injectable – Watson Labs
FDA approved ANDA087274 for two hydroxyzine hydrochloride injectable products from Watson Labs; both are now listed as discontinued.
Regulatory Updates
Aug 25, 2026•1 min read
FDA Approves ANDA086746 for Amitriptyline Tablet – Lederle
FDA approved application ANDA086746 for an oral amitriptyline hydrochloride 25 mg tablet submitted by Lederle; the product is listed as discontinued.
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Regulatory Updates
Aug 25, 2026•1 min read
FDA ANDA 086095: Watson Labs Chlorpheniramine Injection Discontinued
The FDA lists ANDA 086095 for Watson Labs' chlorpheniramine maleate injectable (100 mg/mL). The product is marked discontinued.
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Regulatory Updates
Aug 24, 2026•1 min read
FDA Approves ANDA078070 for Valacyclovir Hydrochloride Tablets by Pharmobedient
The FDA approved application ANDA078070 submitted by Pharmobedient for oral valacyclovir hydrochloride tablets (500 mg and 1 g equivalents). Both products are listed as discontinued.
Regulatory Updates
Aug 24, 2026•1 min read
FDA Approves Padagis Israel’s Desoximetasone 0.25% Topical Ointment (ANDA077770)
The FDA granted approval (ANDA077770) for Padagis Israel’s prescription topical ointment containing 0.25% desoximetasone.
Regulatory Updates
Aug 24, 2026•1 min read
FDA Approves ANDA077168 for Fluticasone Propionate Topical Ointment by Cosette Pharmaceuticals
The FDA has approved ANDA077168 for a prescription topical ointment containing 0.005% fluticasone propionate, manufactured by Cosette Pharmaceuticals.
Regulatory Updates
Aug 24, 2026•1 min read
FDA Approves ANDA076877 for Gabapentin Tablets (Discontinued)
FDA approved ANDA076877 for gabapentin 600mg and 800mg oral tablets submitted by Senores Pharms; both products are listed as discontinued.