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Generated: January 23, 2019

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Details for New Drug Application (NDA): 020001

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NDA 020001 describes CAPEX, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from one supplier. Additional details are available on the CAPEX profile page.

The generic ingredient in CAPEX is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 020001
Applicant:Galderma Labs Lp
Ingredient:fluocinolone acetonide
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020001
Suppliers and Packaging for NDA: 020001
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPEX fluocinolone acetonide SHAMPOO;TOPICAL 020001 NDA Galderma Laboratories, L.P. 0299-5500 0299-5500-04 1 KIT in 1 CARTON (0299-5500-04) * 12 mg in 1 PACKAGE * 118 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SHAMPOO;TOPICALStrength0.01%
Approval Date:Aug 27, 1990TE:RLD:Yes

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