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U.S. Department of Health and Human Services

Drugs

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First-Time Generics - May 2001

Approval DateDrug NameANDA NumberSupplement Number
5/10/01FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 0.4 MG/ML (20 MG/50 ML) SINGLE-DOSE IN GALAXY PLASTIC CONTAINER.75-591 
5/24/01PRIMIDONE TABLETS, USP 50 MG84-903S-015
5/24/01AMINOCAPROIC ACID TABLETS, USP 500 MG75-602 
5/25/01PERPHENAZINE ORAL SOLUTION, USP 16 MG/5 ML (CONCENTRATE)40-360 
5/25/01NORETHINDRONE ACETATE TABLETS, USP 5 MG75-951 
5/29/01CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, USP 1%/0.05% (BASE)75-673 
5/31/01FAMOTIDINE TABLETS, USP 10 MG (OVER-THE COUNTER USE)75-312