🇺🇸 Muscle relaxant therapy in United States

FDA authorised Muscle relaxant therapy on 31 August 1995

Marketing authorisations

FDA — authorised 31 August 1995

  • Application: ANDA074334
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: VECURONIUM BROMIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 23 August 1999

  • Application: ANDA075218
  • Marketing authorisation holder: HIKMA
  • Local brand name: VECURONIUM BROMIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 25 August 1999

  • Application: ANDA074688
  • Marketing authorisation holder: MEITHEAL
  • Local brand name: VECURONIUM BROMIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 21 October 1999

  • Application: ANDA075164
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: VECURONIUM BROMIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 13 June 2000

  • Application: ANDA075549
  • Marketing authorisation holder: HIKMA
  • Local brand name: VECURONIUM BROMIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 11 September 2001

  • Application: ANDA075558
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: VECURONIUM BROMIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 29 December 2008

  • Application: ANDA078274
  • Marketing authorisation holder: SAGENT PHARMS INC
  • Local brand name: VECURONIUM BROMIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 17 June 2009

  • Application: ANDA079001
  • Marketing authorisation holder: SUN PHARM
  • Local brand name: VECURONIUM BROMIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 11 May 2010

  • Application: ANDA090243
  • Marketing authorisation holder: MYLAN LABS LTD
  • Local brand name: VECURONIUM BROMIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 26 May 2016

  • Application: ANDA205390
  • Marketing authorisation holder: GLAND
  • Local brand name: VECURONIUM BROMIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 20 December 2018

  • Application: ANDA206670
  • Marketing authorisation holder: EUGIA PHARMA
  • Local brand name: VECURONIUM BROMIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 30 July 2019

  • Application: ANDA203725
  • Marketing authorisation holder: HIKMA
  • Local brand name: VECURONIUM BROMIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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Other Musculoskeletal/Pain Management approved in United States

Frequently asked questions

Is Muscle relaxant therapy approved in United States?

Yes. FDA authorised it on 31 August 1995; FDA authorised it on 23 August 1999; FDA authorised it on 25 August 1999.

Who is the marketing authorisation holder for Muscle relaxant therapy in United States?

WATSON LABS holds the US marketing authorisation.