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Approved drug products with therapeutic equivalence evaluations.

[Rockville, Md.] : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drugs and Biologics ; Washington, D.C. : For sale by the Supt. of Docs., U.S. G.P.O., 1985- 1985

Approved drug products with therapeutic equivalence evaluations

[Rockville, Md.] : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drugs and Biologics ; Washington, D.C. : For sale by the Supt. of Docs., U.S. G.P.O. 1985

Guidance for industry alternate source of the active pharmaceutical ingredient in pending ANDAs.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2000] 2000

Guidance for industry ANDAs, impurities in drug products.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2005] 2005

Guidance for industry ANDAs, impurities in drug substances.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2009] 2009

Guidance for industry ANDAs, pharmaceutical solid polymorphism, chemistry, manufacturing and control

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2007] 2007

Guidance for industry major, minor, and telephone amendments to abbreviated new drug applications.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2001] 2001

Guidance for industry potassium chloride modified-release tablets and capsules, in vivo bioequivalen

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2005] 2005

Guidance for industry revising and ANDA labeling following revision of the RLD labeling.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2000] 2000

Orange book approved drug products with therapeutic equivalence evaluations.

[Rockville, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs 1985