FDA Guidance Document: ANDAs: Pharmaceutical Solid Polymorphism — Chemistry, Manufacturing, And Controls Information
Source: Food and Drug Administration (FDA)
Chemistry, manufacturing, and controls (CMC) information must be submitted to support the approval of an abbreviated new drug application (ANDA). This guidance is intended to assist applicants with the submission of ANDAs when a drug substance exists in polymorphic forms. Submitted by the Food and Drug Administration (FDA)
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