🇺🇸 Brevital Sodium in United States

FDA authorised Brevital Sodium on 27 June 1960

Marketing authorisations

FDA — authorised 27 June 1960

  • Marketing authorisation holder: PAR STERILE PRODUCTS
  • Status: approved

FDA — authorised 27 June 1960

  • Application: NDA011559
  • Marketing authorisation holder: PH HEALTH
  • Local brand name: BREVITAL SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 3 October 2024

  • Application: ANDA215488
  • Marketing authorisation holder: ONESOURCE SPECIALTY
  • Status: approved

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Brevital Sodium in other countries

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

Other Metabolic approved in United States

Frequently asked questions

Is Brevital Sodium approved in United States?

Yes. FDA authorised it on 27 June 1960; FDA authorised it on 27 June 1960; FDA authorised it on 3 October 2024.

Who is the marketing authorisation holder for Brevital Sodium in United States?

PAR STERILE PRODUCTS holds the US marketing authorisation.