🇺🇸 Phenergan in United States

FDA authorised Phenergan on 29 March 1951

Marketing authorisations

FDA — authorised 29 March 1951

  • Application: NDA007935
  • Marketing authorisation holder: DELCOR ASSET CORP
  • Local brand name: PHENERGAN
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 20 August 1956

  • Application: NDA008857
  • Marketing authorisation holder: WYETH AYERST
  • Local brand name: PHENERGAN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 5 May 1958

  • Application: NDA010926
  • Marketing authorisation holder: NORVIUM BIOSCIENCE
  • Local brand name: PHENERGAN
  • Indication: SUPPOSITORY — RECTAL
  • Status: approved

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FDA — authorised 27 April 1960

  • Application: NDA011689
  • Marketing authorisation holder: PHARMOBEDIENT
  • Local brand name: PHENERGAN
  • Indication: SUPPOSITORY — RECTAL
  • Status: approved

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FDA

  • Application: ANDA086523
  • Marketing authorisation holder: MAST MM
  • Local brand name: PHENAZINE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA

  • Application: ANDA086525
  • Marketing authorisation holder: MAST MM
  • Local brand name: PHENAZINE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA

  • Application: ANDA089013
  • Marketing authorisation holder: CENCI
  • Local brand name: PROMETHAZINE
  • Indication: SYRUP — ORAL
  • Status: approved

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FDA

  • Application: ANDA087305
  • Marketing authorisation holder: MAST MM
  • Local brand name: PHENAZINE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA086524
  • Marketing authorisation holder: MAST MM
  • Local brand name: PHENAZINE
  • Indication: CAPSULE — ORAL
  • Status: approved

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Other Other approved in United States

Frequently asked questions

Is Phenergan approved in United States?

Yes. FDA authorised it on 29 March 1951; FDA authorised it on 20 August 1956; FDA authorised it on 5 May 1958.

Who is the marketing authorisation holder for Phenergan in United States?

DELCOR ASSET CORP holds the US marketing authorisation.