🇺🇸 Pharmacological ascorbate in United States

FDA authorised Pharmacological ascorbate on 28 July 1947

Marketing authorisations

FDA — authorised 28 July 1947

  • Application: NDA006071
  • Marketing authorisation holder: ROCHE
  • Local brand name: BEROCCA PN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 20 February 1953

  • Application: NDA008809
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: M.V.I.-12 ADULT
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 13 July 1982

  • Application: NDA018439
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: MVC PLUS
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 29 December 1993

  • Application: NDA020176
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: VITAPED
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 21 February 2001

  • Application: NDA021265
  • Marketing authorisation holder: SANDOZ CANADA INC
  • Local brand name: INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)
  • Indication: INJECTABLE — INTRAVENOUS
  • Status: approved

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FDA — authorised 30 January 2004

  • Application: NDA021625
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: M.V.I. ADULT
  • Indication: INJECTABLE — INTRAVENOUS
  • Status: approved

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FDA — authorised 2 October 2017

  • Application: NDA209112
  • Marketing authorisation holder: MCGUFF
  • Local brand name: ASCOR
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

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FDA — authorised 7 August 2025

  • Application: ANDA217131
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: ASCORBIC ACID
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

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FDA — authorised 21 April 2026

  • Application: ANDA210456
  • Marketing authorisation holder: APOTEX
  • Local brand name: MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE)
  • Indication: INJECTABLE — INTRAVENOUS
  • Status: approved

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FDA — authorised 21 April 2026

  • Application: ANDA210671
  • Marketing authorisation holder: APOTEX
  • Local brand name: MULTIPLE VITAMINS INJECTION PEDIATRIC
  • Indication: INJECTABLE — INTRAVENOUS
  • Status: approved

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FDA

  • Application: NDA018933
  • Marketing authorisation holder: TELIGENT
  • Local brand name: M.V.I.-12 LYOPHILIZED
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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Frequently asked questions

Is Pharmacological ascorbate approved in United States?

Yes. FDA authorised it on 28 July 1947; FDA authorised it on 20 February 1953; FDA authorised it on 13 July 1982.

Who is the marketing authorisation holder for Pharmacological ascorbate in United States?

ROCHE holds the US marketing authorisation.