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Last Updated: January 21, 2021

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Details for New Drug Application (NDA): 205931

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NDA 205931 describes ACTICLATE, which is a drug marketed by Almirall and is included in two NDAs. Additional details are available on the ACTICLATE profile page.

The generic ingredient in ACTICLATE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 205931
Tradename:ACTICLATE
Applicant:Almirall
Ingredient:doxycycline hyclate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Jul 25, 2014TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Jul 25, 2014TE:ABRLD:Yes

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