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Generated: November 18, 2018

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Details for New Drug Application (NDA): 017765

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NDA 017765 describes CLODERM, which is a drug marketed by Promius Pharma Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the CLODERM profile page.

The generic ingredient in CLODERM is clocortolone pivalate. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the clocortolone pivalate profile page.
Summary for 017765
Tradename:CLODERM
Applicant:Promius Pharma Llc
Ingredient:clocortolone pivalate
Patents:0
Pharmacology for NDA: 017765
Suppliers and Packaging for NDA: 017765
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLODERM clocortolone pivalate CREAM;TOPICAL 017765 NDA AUTHORIZED GENERIC Dr. Reddy's Laboratories Inc 43598-341 43598-341-45 1 TUBE in 1 CARTON (43598-341-45) > 45 g in 1 TUBE
CLODERM clocortolone pivalate CREAM;TOPICAL 017765 NDA AUTHORIZED GENERIC Dr. Reddy's Laboratories Inc 43598-341 43598-341-75 1 BOTTLE, PUMP in 1 CARTON (43598-341-75) > 75 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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