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Details for New Drug Application (NDA): 017001

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NDA 017001 describes ANCOBON, which is a drug marketed by Valeant and is included in one NDA. It is available from two suppliers. Additional details are available on the ANCOBON profile page.

The generic ingredient in ANCOBON is flucytosine. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the flucytosine profile page.

Summary for NDA: 017001

Therapeutic Class:Antifungals

Pharmacology for NDA: 017001

Ingredient-typeNucleoside Analog

Suppliers and Packaging for NDA: 017001

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 017001 NDA Valeant Pharmaceuticals North America LLC 0187-3554 0187-3554-10 100 CAPSULE in 1 BOTTLE (0187-3554-10)
CAPSULE;ORAL 017001 NDA Valeant Pharmaceuticals North America LLC 0187-3555 0187-3555-10 100 CAPSULE in 1 BOTTLE (0187-3555-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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