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Generated: December 18, 2017

DrugPatentWatch Database Preview

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 three suppliers. Additional details are available on the ANCOBON profile page.

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

Summary for 017001

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 017001

Ingredient-typeNucleoside Analog

Medical Subject Heading (MeSH) Categories for 017001

Suppliers and Packaging for NDA: 017001

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

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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Julphar

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