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U.S. Department of Health and Human Services

Drugs

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Approvals - October 2004

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-450METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  PUREPAC PHARMACEUTICAL COMPANY10/1/2004 
276-523MEFLOQUINE HYDROCHLORIDE TABLETS 250 MG  ROXANE LABORATORIES, INC.10/1/2004 
376-277RIBAVIRIN CAPSULES 200 MG  TEVA PHARMACEUTICALS USA10/4/2004 
476-895PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 15 MG (BASE)/5 ML  MORTON GROVE PHARMACEUTICALS, INC.10/4/2004 
575-565LORATADINE ORAL SOLUTION, USP (OTC) 5 MG/5 ML  APOTEX INC.10/5/2004 
676-674LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG  APOTEX INC.10/5/2004 
776-271KETOROLAC TROMETHAMINE INJECTION, USP 15 MG/ML; 30 MG/ML, AND 60 MG/2 ML SINGLE-DOSE VIALS  SABEX 2002 INC.10/6/2004 
876-912CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG  TARO PHARMACEUTICAL INDUSTRIES LTD.10/6/2004 
975-435GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG  TEVA PHARMACEUTICALS USA, INC.10/8/2004 
1076-188FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG  SANDOZ INC.10/8/2004 
1176-256FLUMAZENIL INJECTION 0.1 MG/ML; PACKAGED IN 0.5 MG/5 ML AND 1 MG/10 ML MULTIPLE DOSE VIALS  BEDFORD LABORATORIES10/12/2004 
1276-582FENOLDOPAM MESYLATE INJECTION, USP 10 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/1 ML AND 20 MG (BASE)/2 ML SINGLE-DOSE VIALS  BEDFORD LABORATORIES10/12/2004 
1376-589FLUMAZENIL INJECTION 0.1 MG/ML; PACKAGED IN 0.5 MG/5 ML AND 1 MG/10 ML MULTIPLE-DOSE VIALS  SICOR PHARMACEUTICALS, INC.10/12/2004 
1476-753BETAMETHASONE DIPROPIONATE OINTMENT, USP (AUGMENTED) 0.05% (BASE)  TARO PHARMACEUTICALS U.S.A., INC.10/12/2004 
1576-755FLUMAZENIL INJECTION 0.1 MG/ML; PACKAGED IN 0.5 MG/5 ML AND 1 MG/10 ML MULTIPLE-DOSE VIALS  APOTEX CORP.10/12/2004 
1676-787FLUMAZENIL INJECTION 0.1 MG/ML; PACKAGED IN 0.5 MG/5 ML AND 1 MG/10 ML MULTIPLE DOSE VIALS  BAXTER HEALTHCARE CORPORATION10/12/2004 
1776-955FLUMAZENIL INJECTION 0.1 MG/ML; PACKAGED IN 0.5 MG/5 ML AND 1 MG/10 ML MULTIPLE DOSE VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.10/12/2004 
1876-099CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG SINGLE-DOSE VIALS  BEDFORD LABORATORIES10/14/2004 
1976-162CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG SINGLE-DOSE VIALS  PHARMACHEMIE B.V.10/14/2004 
2076-235CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG SINGLE-DOSE VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.10/14/2004 
2176-517CARBOPLATIN INJECTION 10 MG/ML; PACKAGED IN 50 MG/5 ML, 150 MG/15 ML, AND 450 MG/45 ML SINGLE-DOSE VIALS  MAYNE PHARMA (USA), INC.10/14/2004 
2276-863METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 750 MG  BARR LABORATORIES, INC.10/14/2004 
2377-269CARBOPLATIN INJECTION 10 MG/ML; PACKAGED IN 50 MG/5 ML, 150 MG/15 ML, AND 450 MG/45 ML MULTIPLE-DOSE VIALS.  PHARMACHEMIE B.V.10/14/2004 
2476-276LEVOFLOXACIN TABLETS 250 MG AND 500 MG  MYLAN PHARMACEUTICALS, INC.10/15/2004 
2576-620FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG  ANDRX PHARMACEUTICALS, LLC10/15/2004 
2677-244CARBOPLATIN INJECTION 10 MG/ML; PACKAGED IN 50 MG/5 ML, 150 MG/15 ML, AND 450 MG/45 ML SINGLE-DOSE VIALS  BEDFORD LABORATORIES10/15/2004 
2765-143CEFAZOLIN FOR INJECTION, USP 10 GRAM/VIAL; (PHARMACY BULK PACKAGE)  HIKMA FARMACEUTICA (PORTUGAL), LDA10/18/2004 
2865-190CEFUROXIME AXETIL TABLETS, USP 250 MG (BASE) AND 500 MG (BASE)  TEVA PHARMACEUTICALS, USA10/18/2004 
2975-694GABAPENTIN TABLETS 600 MG AND 800 MG  PUREPAC PHARMACEUTICAL CO.10/21/2004 
3077-247CARBOPLATIN INJECTION 10 MG/ML; PACKAGED IN 50 MG/5 ML, 150 MG/15 ML, AND 450 MG/45 ML MULTIPLE-DOSE VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.10/21/2004 
3176-921MIRTAZAPINE TABLETS 7.5 MG, 15 MG, 30 MG, AND 45 MG  AUROBINDO PHARMA LIMITED10/22/2004 
3276-316SODIUM CHLORIDE INJECTION, USP 0.9%; PACKAGED IN 500 ML SINGLE-DOSE FLEXIBLE PLASTIC CONTAINERS  HAEMONETICS CORPORATION10/27/2004 
3376-473CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG SINGLE-DOSE VIALS  MAYNE PHARMA (USA) INC.10/27/2004 
3476-486ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG AND 10 MG/25 MG  APOTEX INC.10/27/2004 
3576-552MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION, USP 150 MG/ML; PACKAGED IN 150 MG/1 ML PREFILLED SYRINGES  SICOR PHARMACEUTICALS, INC.10/27/2004 
3640-551BETHANECHOL CHLORIDE TABLETS, USP 50 MG  AMIDE PHARMACEUTICAL, INC.10/28/2004 
3740-552BETHANECHOL CHLORIDE TABLETS, USP 5 MG  AMIDE PHARMACEUTICAL, INC.10/28/2004 
3840-553BETHANECHOL CHLORIDE TABLETS, USP 10 MG  AMIDE PHARMACEUTICAL, INC.10/28/2004 
3940-554BETHANECHOL CHLORIDE TABLETS, USP 25 MG  AMIDE PHARMACEUTICAL, INC.10/28/2004 
4076-832LITHIUM CARBONATE EXTENDED-RELEASE TABLETS, USP 300 MG  ROXANE LABORATORIES, INC.10/28/2004 
4177-031CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  AUROBINDO PHARMA LIMITED10/28/2004 
4277-033CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  PUREPAC PHARMACEUTICAL CO.10/28/2004 
4377-035CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  EON LABS, INC.10/28/2004 
4477-036CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  COREPHARMA LLC10/28/2004 
4577-038CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  DR. REDDY'S LABORATORIES LIMITED10/28/2004