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Serving leading biopharmaceutical companies globally:

Queensland Health
Boehringer Ingelheim
US Department of Justice

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018726

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NDA 018726 describes WESTCORT, which is a drug marketed by Ranbaxy Labs Ltd and Ranbaxy and is included in two NDAs. It is available from one supplier. Additional details are available on the WESTCORT profile page.

The generic ingredient in WESTCORT is hydrocortisone valerate. There are sixty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.

Summary for 018726

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 018726

Suppliers and Packaging for NDA: 018726

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
WESTCORT hydrocortisone valerate OINTMENT;TOPICAL 018726 NDA Ranbaxy Laboratories Inc. 10631-105 10631-105-15 15 g in 1 TUBE (10631-105-15)
WESTCORT hydrocortisone valerate OINTMENT;TOPICAL 018726 NDA Ranbaxy Laboratories Inc. 10631-105 10631-105-45 45 g in 1 TUBE (10631-105-45)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:OINTMENT;TOPICALStrength0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 8, 1983TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
US Army

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