🇺🇸 Calcitriol (Rocaltrol®) in United States

FDA authorised Calcitriol (Rocaltrol®) on 17 August 1978

Marketing authorisations

FDA — authorised 17 August 1978

  • Application: NDA018044
  • Marketing authorisation holder: ESJAY PHARMA
  • Local brand name: ROCALTROL
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 20 November 1998

  • Application: NDA021068
  • Marketing authorisation holder: ESJAY PHARMA
  • Local brand name: ROCALTROL
  • Indication: SOLUTION — ORAL
  • Status: approved

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Other Endocrinology approved in United States

Frequently asked questions

Is Calcitriol (Rocaltrol®) approved in United States?

Yes. FDA authorised it on 17 August 1978; FDA authorised it on 20 November 1998.

Who is the marketing authorisation holder for Calcitriol (Rocaltrol®) in United States?

ESJAY PHARMA holds the US marketing authorisation.