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U.S. Department of Health and Human Services

Drugs

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Approvals - July 2002

 ANDA NumberDrug NameApplicantApproval Date
175-743LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MGPAR PHARMACEUTICAL, INC.7/1/02
275-752LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MGIVAX PHARMACEUTICALS, INC.7/1/02
375-776LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/ 25 MGIVAX PHARMACEUTICALS, INC.7/1/02
475-783LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MGTEVA PHARMACEUTICALS USA7/1/02
575-869LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MGTEVA PHARMACEUTICALS USA7/1/02
675-903LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MGGENEVA PHARMACEUTICALS TECHNOLOGY CORPOR7/1/02
775-926LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MGGENEVA PHARMACEUTICALS TECHNOLOGY CORP.7/1/02
875-944LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, AND 40 MGRANBAXY LABORATORIES, LTD.7/1/02
975-982TRAMADOL HYDROCHLORIDE TABLETS 50 MGSIDMAK LABORATORIES, INC.7/1/02
1075-994LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MGEON LABS, INC.7/1/02
1175-999LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MGLEK PHARMACEUTICAL AND CHEMICAL COMPANY7/1/02
1276-007LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MGRANBAXY LABORATORIES LIMITED7/1/02
1376-059LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MGWATSON LABORATORIES, INC.7/1/02
1476-063LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, AND 40 MGWEST-WARD PHARMACEUTICAL CORP.7/1/02
1576-071LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MGMYLAN PHARMACEUTICALS, INC.7/1/02
1676-113LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MGMYLAN PHARMACEUTICALS, INC.7/1/02
1776-164LISINOPRIL TABLETS, USP 20 MG, 30 MG, AND 40 MGPUREPAC PHARMACEUTICAL CO.7/1/02
1876-180LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, AND 10 MGPUREPAC PHARMACEUTICAL CO.7/1/02
1976-194LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MGWATSON LABORATORIES, INC.7/1/02
2076-230LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MGPUREPAC PHARMACEUTICAL CO.7/1/02
2176-262LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MGEON LABS INC.7/1/02
2275-895SEVOFLURANE LIQUID FOR INHALATION 100 %BAXTER HEALTHCARE CORPORATION7/2/02
2375-849OXAPROZIN TABLETS 600 MGTEVA PHARMACEUTICALS USA7/3/02
2475-963TRAMADOL HYDROCHLORIDE TABLETS 50 MGABLE LABORATORIES, INC.7/3/02
2576-284TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE), AND 4 MG (BASE)TEVA PHARMACEUTICALS USA7/3/02
2676-286TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE), AND 4 MG (BASE)DR. REDDY'S LABORATORIES, LTD.7/3/02
2775-806NIZATIDINE CAPSULES, USP 150 MG AND 300 MGMYLAN PHARMACEUTICALS, INC.7/5/02
2876-051LABETALOL HYDROCHLORIDE INJECTION, USP 5 MG/ML, PACKAGED IN 20 MG/4 ML AND 40 MG/8 ML SINGLE-USE VIALS; AND 100 MG/20 ML AND 200 MG/40 ML MULTIPLE-DOSE VIALSAPOTEX CORP.7/5/02
2976-178NIZATIDINE CAPSULES, USP 150 MG AND 300 MGEON LABS MANUFACTURING, INC.7/5/02
3075-461NIZATIDINE CAPSULES, USP 150 MG AND 300 MGZENITH GOLDLINE PHARMACEUTICALS, INC.7/8/02
3175-953CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MGDR. REDDY'S LABORATORIES, LTD.7/8/02
3276-265LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MGWEST-WARD PHARMACEUTICAL CORP.7/8/02
3340-437EDETATE DISODIUM INJECTION, USP 150 MG/ML (3 G/20 ML SINGLE-DOSE VIALS)BIONICHE PHARMA (CANADA) LTD.7/9/02
3475-616NIZATIDINE CAPSULES, USP 150 MG AND 300 MGWATSON LABORATORIES, INC.7/9/02
3575-934NIZATIDINE CAPSULES, USP 150 MG AND 300 MGGENPHARM INC.7/9/02
3675-981TRAMADOL HYDROCHLORIDE TABLETS 50 MGTORPHARM7/10/02
3776-095MISOPROSTOL TABLETS 0.1 MG AND 0.2 MGIVAX PHARMACEUTICALS, INC.7/10/02
3840-256PREDNISONE TABLETS, USP 5 MG, AND 10 MGVINTAGE PHARMACEUTICALS, INC.7/12/02
3975-250PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 15 MG (BASE)/5 MLWE PHARMACEUTICALS, INC.7/12/02
4075-974TRAMADOL HYDROCHLORIDE TABLETS 50 MGASTA MEDICA, INC.7/12/02
4176-283TIZANIDINE HYDROCHLORIDE TABLETS 4 MG (BASE)PUREPAC PHARMACEUTICAL CO.7/12/02
4275-857MIDAZOLAM HYDROCHLORIDE INJECTION (PRESERVATIVE-FREE) 1 MG (BASE)/ML PACKAGED IN 2 MG (BASE)/ 2 ML AND 5 MG (BASE)/ 5 ML SINGLE-DOSE VIALS; AND 5 MG (BASE)/ML PACKAGED IN 5 MG (BASE)/1 ML AND 10 MG (BASE)/2 ML SINGLE-DOSE VIALSABBOTT LABORATORIES7/22/02
4375-867IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02% (PACKAGED IN 2.5 ML UNIT DOSE VIALS)ROXANE LABORATORIES, INC.7/22/02
4475-943ETODOLAC EXTENDED-RELEASE TABLETS 400 MG, 500 MG, AND 600 MGEON LABS, INC.7/26/02
4576-268DIGOXIN TABLETS, USP 0.125 MG AND 0.25 MGJEROME STEVENS PHARMACEUTICALS, INC.7/26/02