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Serving leading biopharmaceutical companies globally:

Argus Health
Deloitte
Medtronic
Cerilliant
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Chinese Patent Office
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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201566

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NDA 201566 describes FLUCYTOSINE, which is a drug marketed by Novel Labs Inc, Sigmapharm Labs Llc, and West-ward Pharms Int, and is included in three NDAs. It is available from six suppliers. Additional details are available on the FLUCYTOSINE profile page.

The generic ingredient in FLUCYTOSINE 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 201566

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

Pharmacology for NDA: 201566

Ingredient-typeNucleoside Analog

Medical Subject Heading (MeSH) Categories for 201566

Suppliers and Packaging for NDA: 201566

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUCYTOSINE flucytosine CAPSULE;ORAL 201566 ANDA Rising Pharmaceuticals, Inc. 64980-179 64980-179-03 30 CAPSULE in 1 BOTTLE (64980-179-03)
FLUCYTOSINE flucytosine CAPSULE;ORAL 201566 ANDA Rising Pharmaceuticals, Inc. 64980-179 64980-179-01 100 CAPSULE in 1 BOTTLE (64980-179-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Jun 28, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength500MG
Approval Date:Jun 28, 2011TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Citi
McKinsey
US Army
Dow
Moodys
US Department of Justice
Julphar
McKesson
Queensland Health
Deloitte

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