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Drugs

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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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