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Details for New Drug Application (NDA): 086052

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NDA 086052 describes HYDROCORTISONE ACETATE, which is a drug marketed by Parke Davis, Watson Labs, Cenci, Fera Pharms, Akorn, Bel Mar, Purepac Pharm, Ferndale Labs, 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 fifty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone acetate; pramoxine hydrochloride profile page.

Summary for NDA: 086052

Tradename:
HYDROCORTISONE ACETATE
Applicant:
Purepac Pharm
Ingredient:
hydrocortisone acetate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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