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U.S. Department of Health and Human Services

Drugs

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First-Time Generics - April 2001

 Drug NameANDA NumberApproval Date
1THIOTEPA FOR INJECTION, USP 15 MG/VIAL75-5474/2/01
2FAMOTIDINE INJECTION 10 MG/ML (500 MG/50 ML) PHARMACY BULK PACKAGE75-6844/16/01
3FAMOTIDINE TABLETS, USP 20 MG 40 MG75-3114/16/01
4FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML) VIALS75-6694/16/01
5FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS)75-4884/16/01
6IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS, USP 200 MG/30 MG74-5674/17/01
7THIOTEPA FOR INJECTION, USP 15 MG/VIAL 30 MG/VIAL75-7304/20/01
8PROGESTERONE INJECTION, USP 50 MG/ML (MULTIPLE-DOSE VIAL)75-9064/25/01
9MESNA INJECTION 100 MG/ML; (10 ML MULTIPLE-DOSE VIAL)75-8114/26/01
10LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.1 MG/0.02 MG, RESPECTIVELY; (21-DAY AND 28-DAY CYCLES)75-7964/30/01
11PAMIDRONATE DISODIUM FOR INJECTION 30 MG/VIAL, AND 90 MG/VIAL75-2904/30/01