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Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

FDA SUPAC-IR: Questions and Answers about SUPAC-IR Guidance
Internet:http://www.gmp-compliance.org/guidemgr/files/CDER_GUIDANCE_QALETTER.PDF
Origin/Publisher:FDA Office of Enforcement, HFC-200, 5600 Fishers Lane, Rockville, MD 20857, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
Content:This FDA publication asks questions and gives answers in order to explain in detail the existing SUPAC-IR Guidance on immediate-release solid oral dosage forms.
Document Type:FDA Guidance for Industry

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