🇺🇸 Silvadene in United States

FDA authorised Silvadene on 26 November 1973

Marketing authorisations

FDA — authorised 26 November 1973

  • Application: NDA017381
  • Marketing authorisation holder: KING PHARMS LLC
  • Local brand name: SILVADENE
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 25 February 1982

  • Application: NDA018578
  • Marketing authorisation holder: DR REDDYS
  • Local brand name: SSD AF
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 23 December 1985

  • Application: NDA018810
  • Marketing authorisation holder: THEPHARMANETWORK LLC
  • Local brand name: THERMAZENE
  • Indication: CREAM — TOPICAL
  • Status: approved

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FDA — authorised 30 November 1989

  • Application: NDA019608
  • Marketing authorisation holder: FRANKLIN PHARMS
  • Local brand name: SILDAFLO
  • Indication: DRESSING — TOPICAL
  • Status: approved

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FDA

  • Status: approved

Silvadene in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Infectious Disease approved in United States

Frequently asked questions

Is Silvadene approved in United States?

Yes. FDA authorised it on 26 November 1973; FDA authorised it on 25 February 1982; FDA authorised it on 23 December 1985.

Who is the marketing authorisation holder for Silvadene in United States?

KING PHARMS LLC holds the US marketing authorisation.