FDA Guidance for Industry: Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs (Posted 12/12/2000)
Title:
FDA Guidance for Industry: Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs (Posted 12/12/2000)
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072853.pdf
Content:
This guidance is intended to descibe the Office of Generic Drugs' policy on the use of alternate sources of APIs in unapproved abbreviated ANDAs