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Generated: March 23, 2018

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Details for New Drug Application (NDA): 040259

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NDA 040259 describes HYDROCORTISONE ACETATE, which is a drug marketed by Cenci, Ferndale Labs, Parke Davis, Purepac Pharm, Akorn, Bel Mar, Watson Labs, Fera Pharms, X Gen Pharms, and Vintage Pharms, and is included in thirteen NDAs. Additional details are available on the HYDROCORTISONE ACETATE profile page.

The generic ingredient in HYDROCORTISONE ACETATE is hydrocortisone acetate; pramoxine hydrochloride. There are sixty-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate; pramoxine hydrochloride profile page.
Summary for 040259
Applicant:Ferndale Labs
Ingredient:hydrocortisone acetate
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength2.5%
Approval Date:Jul 29, 1999TE:RLD:No

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