Understanding Generic Drugs #marketing #pharmaceuticals


Posted On Aug 11 2017 by

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Understanding Generic Drugs

Generic drugs are important options that allow greater access to health care for all Americans. They are copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.

Health care professionals and consumers can be assured that FDA approved generic drug products have met the same rigid standards as the innovator drug. All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs. And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs.

About Generic Drugs

News and Alerts

Spotlight

  • The Generic Drug Approval Process
  • Office of Generic Drugs (OGD) Annual Report for 2015
  • Generic Drug Review Dashboard Report
  • ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits (PDF – 326KB)

Industry Resources

  • Generic Drugs: Information for Industry
  • Abbreviated New Drug Application (ANDA): Generics
  • Office of Generic Drugs
  • Generic Drug User Fee Amendments of 2012

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Last Updated on: August 11th, 2017 at 5:01 am, by


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