🇺🇸 Danazol Capsules in United States

FDA authorised Danazol Capsules on 21 June 1976

Marketing authorisation

FDA — authorised 21 June 1976

  • Application: NDA017557
  • Marketing authorisation holder: SANOFI AVENTIS US
  • Local brand name: DANOCRINE
  • Indication: CAPSULE — ORAL
  • Status: approved

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Frequently asked questions

Is Danazol Capsules approved in United States?

Yes. FDA authorised it on 21 June 1976.

Who is the marketing authorisation holder for Danazol Capsules in United States?

SANOFI AVENTIS US holds the US marketing authorisation.