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Serving leading biopharmaceutical companies globally:

Argus Health
QuintilesIMS
Boehringer Ingelheim
Citi
McKinsey
Farmers Insurance
Queensland Health
Daiichi Sankyo
McKesson
Healthtrust

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200510

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NDA 200510 describes CLADRIBINE, which is a drug marketed by Fresenius Kabi Usa, Mylan Labs Ltd, and West-ward Pharms Int, and is included in three NDAs. It is available from three suppliers. Additional details are available on the CLADRIBINE profile page.

The generic ingredient in CLADRIBINE is cladribine. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cladribine profile page.
Summary for 200510
Tradename:CLADRIBINE
Applicant:Mylan Labs Ltd
Ingredient:cladribine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200510
Medical Subject Heading (MeSH) Categories for 200510
Suppliers and Packaging for NDA: 200510
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLADRIBINE cladribine INJECTABLE;INJECTION 200510 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-0086 0069-0086-18 10 mL in 1 VIAL (0069-0086-18)
CLADRIBINE cladribine INJECTABLE;INJECTION 200510 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-0201 0069-0201-01 10 mL in 1 VIAL (0069-0201-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Oct 6, 2011TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Cerilliant
Moodys
Farmers Insurance
US Army
Citi
Cipla
Fuji
Medtronic
Fish and Richardson

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