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Tentative Approvals - July 2002

  ANDA Number Drug Name Applicant Tentative Approval Date
1 75-706 LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABLETS 10 MG/240 MG (24-HOUR FORMULATION) ANDRX PHARMACEUTICALS, LLC 7/9/02
2 75-919 MOMETASONE FUROATE TOPICAL SOLUTION, USP 0.1% ALTANA INC. 7/10/02
3 76-171 MOMETASONE FUROATE CREAM, USP 0.1% ALTANA INC. 7/10/02
4 76-179 TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) AND 20 MG (BASE) ANDRX PHARMACEUTICALS, INC. 7/10/02
5 76-217 AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML (PACKAGED IN 150 MG/3 ML VIALS) BIONICHE PHARMA (CANADA) LTD. 7/10/02
6 76-088 AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML (PACKAGED IN 150 MG/3 ML SINGLE-USE VIALS); PRESERVATIVE-FREE BEN VENUE LABORATORIES, INC. 7/17/02
7 76-173 RILUZOLE TABLETS 50 MG IMPAX LABORATORIES, INC. 7/17/02
8 75-711 ALENDRONATE SODIUM TABLETS 5 MG, 10 MG, AND 40 MG IVAX PHARMACEUTICALS, INC. 7/24/02
9 75-923 OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 10 MG, 20 MG, 40 MG, AND 80 MG ENDO PHARMACEUTICALS, INC. 7/31/02

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FDA/Center for Drug Evaluation and Research
Last Updated: August 9, 2002
Originator: OGC
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