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Generated: April 23, 2018

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Details for New Drug Application (NDA): 040398

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NDA 040398 describes MICORT-HC, which is a drug marketed by Sebela Ireland Ltd and is included in two NDAs. It is available from one supplier. Additional details are available on the MICORT-HC profile page.

The generic ingredient in MICORT-HC is hydrocortisone acetate. There are sixty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate profile page.
Summary for 040398
Tradename:MICORT-HC
Applicant:Sebela Ireland Ltd
Ingredient:hydrocortisone acetate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength2%
Approval Date:Mar 29, 2002TE:RLD:No

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