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Generated: November 17, 2018

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Details for New Drug Application (NDA): 087204

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NDA 087204 describes CROTAN, which is a drug marketed by Marnel Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the CROTAN profile page.

The generic ingredient in CROTAN is crotamiton. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the crotamiton profile page.
Summary for 087204
Tradename:CROTAN
Applicant:Marnel Pharms
Ingredient:crotamiton
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 087204
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CROTAN crotamiton LOTION;TOPICAL 087204 ANDA Marnel Pharmaceuticals, Inc. 0682-0051 0682-0051-10 237 g in 1 BOTTLE, PLASTIC (0682-0051-10)
CROTAN crotamiton LOTION;TOPICAL 087204 ANDA Marnel Pharmaceuticals, Inc. 0682-0051 0682-0051-20 60 g in 1 BOTTLE, PLASTIC (0682-0051-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength10%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

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