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Details for New Drug Application (NDA): 207133

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NDA 207133 describes FLURANDRENOLIDE, which is a drug marketed by Alpharma Us Pharms, Perrigo Uk Finco, and Teligent Pharma Inc, and is included in five NDAs. It is available from three suppliers. Additional details are available on the FLURANDRENOLIDE profile page.

The generic ingredient in FLURANDRENOLIDE is flurandrenolide. There are four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the flurandrenolide profile page.

Summary for NDA: 207133

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

Pharmacology for NDA: 207133

Suppliers and Packaging for NDA: 207133

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOTION;TOPICAL 207133 ANDA Perrigo New York Inc 45802-928 45802-928-03 1 BOTTLE, PLASTIC in 1 CARTON (45802-928-03) > 120 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.05%
Approval Date:Aug 30, 2016TE:ATRLD:No

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