🇺🇸 GONADORELIN HYDROCHLORIDE in United States

FDA authorised GONADORELIN HYDROCHLORIDE on 30 September 1982

Marketing authorisations

FDA — authorised 30 September 1982

  • Application: NDA018123
  • Marketing authorisation holder: HIKMA
  • Local brand name: FACTREL
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Status: approved

GONADORELIN HYDROCHLORIDE in other countries

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

Frequently asked questions

Is GONADORELIN HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 30 September 1982; FDA has authorised it.

Who is the marketing authorisation holder for GONADORELIN HYDROCHLORIDE in United States?

HIKMA holds the US marketing authorisation.