2002 strong year for generic approvals


Generic approvals for the first time in 2002.


2002 strong year for generic product approvals

The year 2002 proved to be overwhelmingly positive for generic product approvals. January started out very strong, with a record number of approvals according to Totowa, N.J.-based E.W. Thwaite Associates Inc. In February 2002, there were 41 chemical and 74 dosage form approvals. Approvals in March dipped slightly but climbed back up in April and May. June approvals dropped and picked back up again in July. August and September were slightly weaker, but the year ended on an upbeat note with October, November, and December coming on strong. In December, there were 26 chemical and 46 dosage form approvals. The chart below lists the generic agents that were approved for the first time in 2002.


Generic name
Albuterol extended-release tablets, 4 mg, 8 mg
Amantadine HCl tablets, 100 mg
Amcinonide cream, lotion, and ointment, USP 0.1%
Altana, Taro
Amiodarone HCl injection, 50 mg/ml
Abbott, APP, Bedford, Ben Venue, Bioniche, Faulding
Ammonium lactate cream or lotion, 12% (base)
Clay-Park Labs, Paddock
Amoxicillin for oral suspension, USP 200 mg/5 ml, 400 mg/5 ml
Ranbaxy, TEVA
Amoxicillin and clavulanate potassium for oral suspension, USP 200 mg/28.5 mg (base)/5 ml, 400 mg/57 mg (base)/5 ml
Geneva, Lek
Amoxicillin and clavulanate potassium tablets, USP 500 mg/125 mg (base), 875 mg/125 mg (base) chewable tablets, USP 200 mg/28.5 mg (base), 400 mg/57 mg (base)
Geneva, Lek, Ranbaxy, TEVA
Amphetamine and dextroamphetamine (total mixed salts), 5 mg, 10 mg, 20 mg, 30 mg
Ampicillin and sulbactam for injection, USP 1.5 gm (1 gm/500 mg); 3 gm (2 gm/1 gm); 15-gm pharmacy bulk package (10 gm/5 gm)
ESI Lederle
Calcitriol injection, 0.001 mg/ml, 0.002 mg/ml
Carbamazepine chewable tablets, USP 200 mg (new strength)
Cefaclor extended-release tablets, USP 375 mg, 500 mg
Cefpodoxime proxetil for oral suspension, 50 mg (base)/5 ml, 100 mg (base)/5 ml
Cefuroxime axetil tablets, USP 125 mg (base), 250 mg (base), 500 mg (base)
Ciprofloxacin tablets, USP 100 mg, 250 mg, 500 mg, 750 mg
Dr. Reddy’s
Clindamycin phosphate lotion, USP 1% (base) topical suspension
Cyclosporine capsules, USP 25 mg, 100 mg
Desogestrel/ethinyl estradiol and ethinyl estradiol tablets, 0.15 mg/0.02 mg and 0.01 mg (28-day cycle)
Diflorasone diacetate cream, USP 0.05% (emollient)
Diltiazem HCl for injection, 100-mg vials
Dimethyl sulfoxide irrigation, USP 50%
Doxycycline tablets, 75 mg (new strength)
Econazole nitrate cream, 1%
Altana, Taro
Ethosuximide capsules, USP 250 mg
Fenofibrate capsules (micronized), 134 mg, 200 mg
Fludrocortisone acetate tablets, USP 0.1 mg
Flunisolide nasal solution, USP 0.025% (25 mcg/spray), 200 metered-spray container
Bausch & Lomb
Hydrocortisone acetate cream, USP 2%
Idarubicin HCl injection, 1 mg/ml (5 mg/5 ml, 10 mg/10 ml, 20 mg/20 ml single-dose vials); idarubicin HCl for injection USP 5-mg, 10-mg, 20-mg single-dose vials
Gensia Sicor
Ifosfamide for injection, USP 1-gm, 3-gm single-dose vials
Ifosfamide injection/mesna injection kit, 50 mg/ml (1 gm/20 ml or 3 gm/60 ml) and 100 mg/ml (1 gm/10 ml), respectively
Gensia Sicor
Isotretinoin capsules, USP 10 mg, 20 mg, 40 mg
GenPharm, Ranbaxy
Ketoprofen, 12.5-mg tablets and caplets
L. Perrigo
Levonorgestrel and ethinyl estradiol tablets, USP 0.1 mg/0.02 mg (21- and 28-day cycles)
Levothyroxine sodium tablets, USP 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.1 mg, 0.112 mg, 0.125 mg, 0.15 mg 0.175 mg, 0.2 mg, 0.3 mg
Lisinopril tablets, USP 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg
Eon, Geneva, IVAX, Lek, Mylan, Par, Purepak Ranbaxy, TEVA, Watson, West-Ward
Lisinopril and hydrochlorothiazide tablets, 10 mg/12.5 mg, 20 mg/12.5 mg, 20 mg/25 mg
Eon, Geneva, IVAX, Mylan, Purepac Ranbaxy, TEVA, Watson, West-Ward
Lithium carbonate extended-release tablets, USP 300 mg
Barr, West-Ward
Loperamide HCl and simethicone chewable tablets, 2 mg/125 mg
L. Perrigo
Mefloquine HCl tablets, 250 mg
Metformin hydrochloride tablets, 500 mg, 850 mg, 1 gm
Andrx, Alphapharm, Barr, Caraco, Eon Geneva, GenPharm, Goldline, Mutual, Mylan Purepac, TEVA, TorPharm, Watson, Zenith
Midazolam HCl syrup, 2 mg (base)/ml
Ranbaxy, Roxane
Milrinone lactate injection, 1 mg (base)/ml, 10 mg (base)/10 ml, 20 mg (base)/20 ml, 50 mg (base)/50 ml single-dose vials
Abbott, APP, Baxter, Bedford ESI Lederle, Faulding, IMS
Milrinone lactate in 5% dextrose injection, 0.2 mg (base)/ml (100-ml or 200-ml single-dose containers for IV infusion)
Abbott, Baxter, ESI Lederle
Misoprostol tablets, 0.1 mg, 0.2 mg
Mometasone furoate ointment, USP 0.1%
Clay-Park Labs
Neomycin sulfate oral solution, USP 125 mg/5 ml
Nifedipine extended-release tablets, USP 90 mg
Nizatidine capsules, USP 150 mg, 300 mg
Eon, GenPharm, Mylan, TEVA, Watson Zenith Goldline
Norethindrone tablets, USP 0.35 mg (28 tablets per blister card)
Norethindrone and ethinyl estradiol tablets, USP 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035 mg (21- and 28-day cycles)
Norgestimate and ethinyl estradiol tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg (28-day cycle)
Ofloxacin injection, 40 mg/ml (10-ml single-dose vials)
Omeprazole delayed-release capsules, 10 mg, 20 mg
Eon, Impax, Kremers


Tony Vecchione. 2002 strong year for generic approvals.

Drug Topics

Generic Supplement;147:20S.

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