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Serving leading biopharmaceutical companies globally:

Cipla
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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201784

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NDA 201784 describes CYTARABINE, which is a drug marketed by Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, Mylan Pharms Inc, Sagent Pharms, Teva Parenteral, and West-ward Pharms Int, and is included in fourteen NDAs. It is available from five suppliers. Additional details are available on the CYTARABINE profile page.

The generic ingredient in CYTARABINE is cytarabine. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cytarabine profile page.

Summary for 201784

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

Pharmacology for NDA: 201784

Medical Subject Heading (MeSH) Categories for 201784

Suppliers and Packaging for NDA: 201784

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYTARABINE cytarabine INJECTABLE;INJECTION 201784 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-0155 0069-0155-01 20 mL in 1 VIAL (0069-0155-01)
CYTARABINE cytarabine INJECTABLE;INJECTION 201784 ANDA Mylan Institutional LLC 67457-452 67457-452-20 1 VIAL in 1 CARTON (67457-452-20) > 20 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Jan 30, 2012TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Healthtrust
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Chinese Patent Office
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Teva

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