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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 211027


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NDA 211027 describes HALCINONIDE, which is a drug marketed by Chartwell Rx, Mylan, and Encube, and is included in three NDAs. It is available from two suppliers. Additional details are available on the HALCINONIDE profile page.

The generic ingredient in HALCINONIDE is halcinonide. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the halcinonide profile page.
Summary for 211027
Tradename:HALCINONIDE
Applicant:Mylan
Ingredient:halcinonide
Patents:0
Pharmacology for NDA: 211027
Medical Subject Heading (MeSH) Categories for 211027
Suppliers and Packaging for NDA: 211027
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALCINONIDE halcinonide CREAM;TOPICAL 211027 ANDA Mylan Pharmaceuticals Inc. 0378-8056 0378-8056-49 1 TUBE in 1 CARTON (0378-8056-49) / 30 g in 1 TUBE
HALCINONIDE halcinonide CREAM;TOPICAL 211027 ANDA Mylan Pharmaceuticals Inc. 0378-8056 0378-8056-60 1 TUBE in 1 CARTON (0378-8056-60) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Aug 12, 2019TE:ABRLD:No

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