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Tentative Approvals - May 2006

  ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 77-101 LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, 0.15 MG/0.03 MG WATSON LABORATORIES, INC. 5/8/2006
2 77-242 GABAPENTIN CAPSULES, 100 MG, 300 MG, AND 400 MG SUN PHARMACEUTICAL INDUSTRIES LTD. 5/12/2006
3 77-525 GABAPENTIN TABLETS, 600 MG AND 800 MG SUN PHARMACEUTICAL INDUSTRIES LTD. 5/12/2006
4 77-844 ABACAVIR SULFATE TABLETS, 300 MG (BASE) AUROBINDO PHARMA LIMITED 5/17/2006
5 77-173 ONDANSETRON INJECTION USP (PRESERVATIVE-FREE), 2 MG/ML; 2 ML VIALS SUN PHARMACEUTICAL INDUSTRIES LTD. 5/19/2006
6 77-956 NEVIRAPINE TABLETS, 200 MG CIPLA LIMITED 5/19/2006
7 77-172 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS SUN PHARMACEUTICAL INDUSTRIES LTD. 5/19/2006
8 76-780 ONDANSETRON INJECTION USP (PRESERVATIVE-FREE), 2 MG/ML; 2 ML VIALS HIKMA FARMACEUTICA (PORTUGAL), LDA 5/22/2006
9 76-781 ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS HIKMA FARMACEUTICA (PORTUGAL), LDA 5/22/2006
10 77-744 SUMATRIPTAN SUCCINATE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) MYLAN PHARMACEUTICALS, INC. 5/23/2006
11 77-540 ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG SYNTHON PHARMACEUTICALS, INC. 5/24/2006
12 76-958 LOSARTAN POTASSIUM TABLETS, 25 MG, 50 MG, AND 100 MG TEVA PHARMACEUTICALS, USA 5/24/2006
13 77-916 EFAVIRENZ TABLETS, 600 MG CIPLA LIMITED 5/24/2006
14 77-459 LOSARTAN POTASSIUM TABLETS, 25 MG, 50 MG, AND 100 MG ROXANE LABORATORIES, INC. 5/25/2006
15 76-052 SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG IVAX PHARMACEUTICALS, INC. 5/25/2006
16 77-904 PRAVASTATIN SODIUM TABLETS, 10 MG, 20 MG, 40 MG, AND 80 MG WATSON LABORATORIES, INC. 5/30/2006
17 76-981 ESCITALOPRAM OXALATE TABLETS, 5 MG, 10 MG, AND 20 MG ALPHAPHARM PTY. LTD. 5/31/2006

 

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Date created: June 9, 2006

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