🇺🇸 Enlon-Plus in United States

FDA authorised Enlon-Plus on 30 January 1987

Marketing authorisations

FDA — authorised 30 January 1987

  • Application: ANDA071295
  • Marketing authorisation holder: ABBVIE
  • Local brand name: ATROPINE
  • Indication: SOLUTION — INTRAMUSCULAR
  • Status: approved

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FDA — authorised 6 November 1991

  • Application: NDA019678
  • Marketing authorisation holder: PHARMOBEDIENT
  • Local brand name: ENLON-PLUS
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 6 November 1991

  • Application: NDA019677
  • Marketing authorisation holder: PHARMOBEDIENT
  • Local brand name: ENLON-PLUS
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 17 January 2002

  • Application: NDA021175
  • Marketing authorisation holder: US ARMY
  • Local brand name: ATNAA
  • Indication: INJECTABLE — INTRAMUSCULAR
  • Status: approved

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FDA — authorised 28 September 2006

  • Application: NDA021983
  • Marketing authorisation holder: MMT
  • Local brand name: DUODOTE
  • Indication: INJECTABLE — INTRAMUSCULAR
  • Status: approved

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FDA

  • Status: approved

Enlon-Plus in other countries

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

Other Ophthalmology approved in United States

Frequently asked questions

Is Enlon-Plus approved in United States?

Yes. FDA authorised it on 30 January 1987; FDA authorised it on 6 November 1991; FDA authorised it on 6 November 1991.

Who is the marketing authorisation holder for Enlon-Plus in United States?

ABBVIE holds the US marketing authorisation.