Nonsterile Semisolid Dosage Forms (SUPAC-SS) Chemistry | Federal Regulations · Congress.wiki

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FDA-1997-D-0380

Nonsterile Semisolid Dosage Forms (SUPAC-SS) Chemistry

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Description

Docket Status: OPEN

Comment Period OpensFeb 5, 2009

Type	Title	Posted	Comments	Status
Other	Guidance for Industry Nonsterile Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation; Guidance	Feb 5, 2009	3

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CONTROLS

OINTMENT

SCALE-UP

POSTAPPROVAL

CREAMS

GELS

LOTIONS

MANUFACTURING

CHEMISTRY