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book (15)

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2004 (15)

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Guidance for industry : changes to an approved NDA or ANDA.
Author: Center for Drug Evaluation and Research (U.S.)
Year: 2004 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Drug approval

Book

Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes.
Author: Center for Drug Evaluation and Research (U.S.)
Year: 2004 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Keywords
Drug approval

Book

Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes.
Author: Center for Drug Evaluation and Research (U.S.)
Year: 2004 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Abstract

Keywords
Drug approval

Book

Guidance for industry : changes to an approved NDA or ANDA.
Author: Center for Drug Evaluation and Research (U.S.)
Year: 2004 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Keywords
Drug approval

Book

Guidance for industry : listed drugs, 30 month stays, and approval of ANDAs and 505(b)(2) applications under Hatch-Waxman, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, questions and answers.
Author: Center for Drug Evaluation and Research (U.S.).
Year: 2004 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Drug approval --- United States.

Book

Guidance for industry : listed drugs, 30 month stays, and approval of ANDAs and 505(b)(2) applications under Hatch-Waxman, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, questions and answers.
Author: Center for Drug Evaluation and Research (U.S.).
Year: 2004 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Drug approval --- United States.

Book

Guidance for industry : botanical drug products.
Author: Center for Drug Evaluation and Research (U.S.)
Year: 2004 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Materia medica, Vegetable --- Drug approval

Book

Guidance for industry : botanical drug products.
Author: Center for Drug Evaluation and Research (U.S.)
Year: 2004 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Materia medica, Vegetable --- Drug approval

Book

Drugs@FDA
Author: Center for Drug Evaluation and Research (U.S.)
Year: 2004 Publisher: Washington D.C. : U.S. Food and Drug Administration, Center for Drug and Evaluation Research.

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Drugs --- Drugs, Nonprescription --- Drug approval --- Pharmaceutical Preparations. --- Drug Approval. --- United States.

Book

Drugs@FDA
Author: Center for Drug Evaluation and Research (U.S.)
Year: 2004 Publisher: Washington D.C. : U.S. Food and Drug Administration, Center for Drug and Evaluation Research.

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Drugs --- Drugs, Nonprescription --- Drug approval --- Pharmaceutical Preparations. --- Drug Approval. --- United States.

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