Showing 1 - 11 results of 11 for search 'Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs', query time: 0.14s Refine Results
  1. 1
    Guidance for industry : alternate source of the active pharmaceutical ingredient in pending ANDAs.
    Published 2000
    “...Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs...”
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    Government Document eBook
  2. 2
    Guidance for industry : ANDAs, impurities in drug substances.
    Published 2009
    “...Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs...”
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    Government Document eBook
  3. 3
    Guidance for industry : ANDAs, pharmaceutical solid polymorphism, chemistry, manufacturing and controls information.
    Published 2007
    “...Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs...”
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    Government Document eBook
  4. 4
    Guidance for industry : bioequivalence recommendations for specific products.
    Published 2007
    “...Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs...”
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    Government Document eBook
  5. 5
    Guidance for industry : major, minor, and telephone amendments to abbreviated new drug applications.
    Published 2001
    “...Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs...”
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    Government Document eBook
  6. 6
    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.
    Published 2004
    “...Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs...”
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    Government Document eBook
  7. 7
    Guidance for industry : potassium chloride modified-release tablets and capsules, in vivo bioequivalence and in vitro dissolution testing.
    Published 2005
    “...Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs...”
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    Government Document eBook
  8. 8
    Guidance for industry : revising and ANDA labeling following revision of the RLD labeling.
    Published 2000
    “...Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs...”
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    Government Document eBook
  9. 9
    Guidance for industry : ANDAs, impurities in drug products.
    Published 2005
    “...Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs...”
    Get full text
    Government Document eBook
  10. 10
    Orange book : approved drug products with therapeutic equivalence evaluations.
    “...Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs...”
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    Government Document Database
  11. 11
    Approved drug products with therapeutic equivalence evaluations.
    “...Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs...”
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    Homepage:
    Government Document Serial
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