Please enable JavaScript to view this page content properly.
Browse Drugs by Name to Find API
ABCDEFGHIJKLMNOPQRSTUVWXYZ0-9
Guidance for Industry Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs (Dec. 2000)
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Office of Generic DrugsThis guidance is intended to describe the Office of Generic Drugs' (OGD) policy on the use of alternate sources of the active pharmaceutical ingredients (API) in unapproved abbreviated new drug applications (ANDAs). The guidance describes the circumstances under which an alternate source can be used. This guidance is intended to decrease the regulatory burden on industry and provide a more consistent approach to pre- and postapproval changes in API sources.This guidance replaces the OGD memorandum dated July 26, 1996, titled, Substitution of an Alternate Source of the New Drug Substance in Unapproved Abbreviated Applications.
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Office of Generic Drugs
This guidance is intended to describe the Office of Generic Drugs' (OGD) policy on the use of alternate sources of the active pharmaceutical ingredients (API) in unapproved abbreviated new drug applications (ANDAs). The guidance describes the circumstances under which an alternate source can be used. This guidance is intended to decrease the regulatory burden on industry and provide a more consistent approach to pre- and postapproval changes in API sources.
This guidance replaces the OGD memorandum dated July 26, 1996, titled, Substitution of an Alternate Source of the New Drug Substance in Unapproved Abbreviated Applications.
180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day [Word] or [PDF] (Issued 7/2003, Posted 7/31/2003)