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FDA Guidance for Industry: Completeness Assessment for Type II API DMFs unter GDUFA
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM321884.pdf
Content:
This draft guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA) or an amendment or prior approval supplement (PAS) to an ANDA (generic drug submissions)
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