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Details for New Drug Application (NDA): 018116

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NDA 018116 describes CYCLOCORT, which is a drug marketed by Astellas and is included in three NDAs. Additional details are available on the CYCLOCORT profile page.

The generic ingredient in CYCLOCORT is amcinonide. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amcinonide profile page.

Summary for NDA: 018116

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength0.025%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength0.1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired Orange Book Patents for NDA: 018116

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas
CYCLOCORT
amcinonide
CREAM;TOPICAL018116-002Approved Prior to Jan 1, 19824,158,055► Subscribe
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