Generic Drug Approvals

First-Time Generic Approvals: Combunox, Dilantin, Antizol The FDA has approved first-time generic formulations for oxycodone hydrochloride and ibuprofen tablets in 5 mg/400 mg strength, extended phenytoin sodium capsules in 30-mg strength, and fomepizole injectable in 1 g/mL strength.
News, December 28, 2007
First-Time Generic Approvals: Procardia XL, Estrostep FE, Estrostep The FDA has approved first-time generic formulations for nifedipine extended-release tablets in 90-mg strength; norethindrone acetate and ethinyl estradiol tablets (28-day) in 1 mg/0.02 mg, 1 mg/0.03 mg, and 1 mg/0.035 mg strengths; and norethindrone acetate and ethinyl estradiol tablets (21-day) in 1 mg/0.02 mg, 1 mg/0.03 mg, and 1 mg/0.035 mg strengths.
News, December 07, 2007
First-Time Generic Approvals: Penlac, Tussionex Pennkinetic, Cerebyx The FDA has approved first-time generic formulations for ciclopirox topical solution (nail lacquer) 8%, hydrocodone polistirex and chlorpheniramine polistirex suspension in 5-mg/4-mg and 10-mg/8-mg strengths, and fosphenytoin sodium injection EQ 50 mg/mL strength.
News, October 26, 2007
First-Time Generic Approvals: AccuNeb, Coreg, Famvir The FDA has approved first-time generic formulations for albuterol sulfate inhalation solution in the 0.021% (base) strength; carvedilol 3.125-, 6.25-, 12.5-, and 25-mg tablets; and famciclovir 125-, 250-, and 500-mg tablets.
News, July 26, 2020
First-Time Generic Approvals: Verelan PM, Cefotan, Nasarel The FDA has approved first-time generic formulations for verapamil hydrochloride 100-, 200-, and 300-mg extended-release capsules; cefotetan disodium injectable EQ 1 gm base/vial and EQ 2 gm base/vial; and flunisolide metered spray 0.029 mg/spray.
News, August 17, 2007
First-Time Generic Approvals: Dantrium, Lexapro Capsules, Protonix The FDA has approved first-time generic formulations for dantrolene sodium injectable 20 mg/vial; escitalopram oxalate capsules EQ 5-mg, 10-mg, and 20-mg base; and pantoprazole sodium delayed-release tablets EQ 20-mg and 40-mg base.
News, August 10, 2007
First-Time Generic Approvals: Paxil CR, Lamisil, Parlodel The FDA has approved first-time generic formulations for paroxetine hydrochloride extended release tablets 12.5 mg and 25 mg, terbinafine hydrochloride 250-mg tablets and terbinafine hydrochloride cream 1%, and bromocriptine mesylate capsules 5 mg.
News, July 12, 2007
First-Time Generic Approvals: Maxipime, Tessalon 200 mg, Vesanoid The FDA has approved generic formulations for cefepime hydrochloride 500 mg, 1-g, and 2-g base/vial for parenteral administration in the treatment of bacterial infections; benzonatate 200 mg for the treatment of cough; and tretinoin 10-mg capsules for the induction of remission in patients with acute promyelocytic leukemia (APL).
News, July 26, 2020
First-Time Generic Approvals: Toprol-XL, Suprax, Lotrel The FDA has approved generic formulations for metoprolol succinate extended-release tablets for treatment of hypertension and other conditions, cefixime oral suspension for treatment of bacterial infections, and amlodipine besylate/benazepril for treatment of hypertension.
News, May 25, 2007
First-Time Generics: Ambien, Zoloft, Nimotop The FDA has approved generic formulations for zolpidem tartrate for treatment of insomnia, sertraline hydrochloride for treatment of depression, and nimodipine for improved neurological outcome following subarachnoid hemorrhage.
News, May 04, 2007
First-Time Generic Approvals: Corzide, Cipro XR, Cortef The FDA has approved first-time generic formulations for nadolol plus bendroflumethiazide 40-mg/5-mg and 80-mg/5-mg tablets (Corzide), ciprofloxacin 500- and 1000-mg extended-release tablets (Cipro XR), and hydrocortisone 5- and 10-mg tablets (Cortef).
News, April 20, 2007
First-Time Generic Approvals: Celexa, Videx, Dermatop The FDA has approved first-time generic formulations for citalopram HBr capsules (Celexa); didanosine pediatric powder for oral solution (Videx Pediatric Powder); and prednicarbate 0.1% ointment (Dermatop).
News, March 16, 2007
First-Time Generic Approvals: Aciphex, Zantac Syrup, Uniretic The FDA has approved first-time generic formulations for rabeprazole sodium delayed-release tablets (Aciphex), ranitidine oral solution/syrup (Zantac), and moexipril HCl plus hydrochlorothiazide tablets (Uniretic).
News, March 13, 2007
First-Time Generic Approvals: Paxil Suspension, Pamine, Mavik The FDA has approved first-time generic formulations for paroxetine HCl 10-mg/5-mL oral suspension (Paxil); methscopolamine bromide 2.5- and 5-mg tablets (Pamine and Pamine Forte); and trandolapril 1-, 2-, and 4-mg tablets (Mavik).
News, January 12, 2007
First-Time Generic Approvals: Oral Zofran, Wellbutrin XL, Kefzol Bulk The FDA has approved generic formulations for ondasetron HCl tablets and oral solution (Zofran); bupropion HCl extended-release tablets (Wellbutrin XL); and cefazolin sodium injection pharmacy bulk packages (Kefzol).
News, January 05, 2007
First-Time Generic Approvals: Ditropan XL, Zofran, Oxandrin The FDA has approved first-time generic formulations for oxybutynin chloride 5-, 10-, and 15-mg extended-release tablets (Ditropan XL); ondasetron HCl 2-mg/mL injection packaged in single and multidose vials (Zofran); premixed 0.64-mg/mL ondasetron injection with 5% dextrose in 50-mL flexible plastic containers (Zofran Injection Premixed); and oxandrolone 2.5- and 10-mg tablets (Oxandrin).
News, December 15, 2006
First-Time Generic Approvals: Klaron, MetroGel-Vaginal, Colestid The FDA has approved first-time generic formulations for sulfacetamide sodium 10% topical solution (Klaron), metronidazole 0.75% vaginal gel (MetroGel-Vaginal), and colestipol HCl 1-g tablets (Colestid).
News, November 21, 2006
First-Time Generic Approvals: Cafcit, Claritin Hives Relief Syrup, Dermatop The FDA has approved first-time generic formulations for caffeine citrate intravenous injection and oral solution (Cafcit); over-the-counter loratadine oral solution (Claritin Hives Relief Syrup); and prednicarbate 0.1% cream (Dermatop E Emollient).
News, September 29, 2006
First-Time Generic Approvals: Cipro IV, Surmontil, Lamictal The FDA has approved first-time generic versions of certain formulations of ciprofloxacin injection (Cipro IV); trimipramine maleate capsules (Surmontil); and lamotrigine tablets (Lamictal).
News, September 06, 2006
First-Time Generic Approvals: Climara, Toprol XL, Effexor The FDA has approved first-time generic formulations of an estradiol transdermal system (Climara), metoprolol succinate extended-release tablets (Toprol XL), and venlafaxine HCl tablets (Effexor).
News, August 11, 2006

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