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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-one suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for NDA: 020001

Suppliers and Packaging for NDA: 020001

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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

Summary for product number 001

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

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