Search Results - Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs
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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 Electronic eBook
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2
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 Electronic eBook -
3
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…”
Online Access
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Government Document Electronic eBook -
4
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…”
Online Access
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Government Document Electronic eBook -
5
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 Electronic eBook -
6
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 Electronic eBook -
7
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,...
Published 2004“…Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs…”
Online Access
Online Access
Government Document Electronic eBook -
8
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 Electronic eBook -
9
Guidance for industry ANDAs, impurities in drug products.
Published 2005“…Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs…”
Online Access
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Government Document Electronic eBook -
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 Continuing Resource -
11
Approved drug products with therapeutic equivalence evaluations.
Published 1985“…Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs…”
Request a PDF (UCB only)
Government Document Serial -
12
Approved drug products with therapeutic equivalence evaluations.
“…Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs…”
Online Access
Online Access
Connect to online resource
Online Access
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Government Document Serial