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Serving leading biopharmaceutical companies globally:

Deloitte
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Fuji
Merck
US Army
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Boehringer Ingelheim
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Generated: October 16, 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 and Sigmapharm Labs Llc and is included in two NDAs. It is available from three 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. Six suppliers are listed for this compound. Additional details are available on the flucytosine profile page.

Summary for NDA: 201566

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

Pharmacology for NDA: 201566

Ingredient-typeNucleoside Analog

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 64980-179-01 100 CAPSULE in 1 BOTTLE (64980-179-01)
FLUCYTOSINE
flucytosine
CAPSULE;ORAL 201566 ANDA Rising Pharmaceuticals, Inc. 64980-179 64980-179-03 30 CAPSULE in 1 BOTTLE (64980-179-03)

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:

Merck
Covington
Express Scripts
Cantor Fitzgerald
McKinsey
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Chinese Patent Office
Dow

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