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Drug Information

Approvals - July 2001

  ANDA Number Drug Name Applicant Approval Date
1 75-702 CROMOLYN SODIUM NASAL SOLUTION, USP 5.2 MG DELIVERED/SPRAY, (40 MG/ML), 26 ML BOTTLE. BAUSCH & LOMB PHARMACEUTICALS, INC. 7/3/01
2 75-712 CARBAMAZEPINE TABLETS, USP (CHEWABLE) 100 MG CARACO PHARMACEUTICAL LABORATORIES, LTD. 7/5/01
3 40-407 PROCHLORPERAZINE SUPPOSITORIES, USP 2.5 MG, 5 MG, AND 25 MG ABLE LABORATORIES, INC. 7/11/01
4 75-735 PENTAZOCINE AND NALOXONE HCL TABLETS, USP 50 MG (BASE)/0.5 MG (BASE) AMIDE PHARMACEUTICAL, INC. 7/11/01
5 75-838 PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/650 MG (WHITE TABLETS AND PINK TABLETS) ABLE LABORATORIES, INC. 7/11/01
6 75-809 LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP TRIPHASIC REGIMEN 0.05 MG/0.03 MG, 0.075 MG/0.04 MG, AND 0.125 MG/0.03 MG; 21-DAY AND 28-DAY CYCLES. DURAMED PHARMACEUTICALS, INC. 7/16/01
7 40-390 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS, USP 50 MG/325 MG/40 MG ABLE LABORATORIES, INC. 7/23/01
8 40-394 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS, USP 50 MG/500 MG/40 MG ABLE LABORATORIES, INC. 7/23/01
9 75-278 PACLITAXEL INJECTION 6 MG/ML; PACKAGED IN 30 MG/5 ML, 100 MG/16.7 ML AND 300 MG/50 ML MULTIPLE-DOSE VIALS. MYLAN PHARMACEUTICALS, INC. 7/23/01
10 75-611 FAMOTIDINE TABLETS, USP 20 MG AND 40 MG TORPHARM 7/23/01
11 75-626 KETOROLAC TROMETHAMINE INJECTION, USP 30 MG/ML (MULTIPLE-DOSE VIALS) APOTEX CORP. 7/24/01
12 75-671 MEGESTROL ACETATE ORAL SUSPENSION 40 MG/ML PAR PHARMACEUTICAL, INC. 7/25/01
13 74-800 CROMOLYN SODIUM NASAL SOLUTION, USP 5.2 MG DELIVERED/SPRAY, (40 MG/ML), 13 ML & 26 ML BOTTLES ALPHARMA, U.S. PHARMACEUTICALS DIVISION 7/26/01
14 75-512 FAMOTIDINE TABLETS, USP (OTC) 10 MG IVAX PHARMACEUTICALS, INC. 7/26/01
15 75-993 LACTULOSE SOLUTION, USP 10 G/15 ML VINTAGE PHARMACEUTICALS, INC. 7/26/01
16 65-081 CEPHALEXIN FOR ORAL SUSPENSION, USP 125 MG/5 ML AND 250 MG/5 ML RANBAXY LABORATORIES LIMITED 7/27/01
17 75-190 PACLITAXEL INJECTION 6 MG/ML; PACKAGED IN 30 MG/5 ML, 100 MG/16.7 ML, AND 300 MG/50 ML MULTIPLE-DOSE VIALS. BEDFORD LABORATORIES 7/27/01
18 75-085 HYDROCORTISONE VALERATE OINTMENT, USP 0.2% ALTANA INC. 7/31/01
19 75-442 FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MG ALPHAPHARM PTY. LTD. 7/31/01

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