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Last Updated: May 28, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210756


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NDA 210756 describes DECITABINE, which is a drug marketed by Accord Hlthcare, Chemi Spa, Cipla, Dr Reddys, Ingenus Pharms Llc, Lupin Ltd, MSN, Pharmascience Inc, Sagent Pharms Inc, Sandoz Inc, Wockhardt Bio Ag, and Sun Pharma Global, and is included in twelve NDAs. It is available from seventeen suppliers. Additional details are available on the DECITABINE profile page.

The generic ingredient in DECITABINE is decitabine. There are eighteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the decitabine profile page.
Summary for 210756
Tradename:DECITABINE
Applicant:Lupin Ltd
Ingredient:decitabine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210756
Suppliers and Packaging for NDA: 210756
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DECITABINE decitabine INJECTABLE;INTRAVENOUS 210756 ANDA Fresenius Kabi USA, LLC 63323-825 63323-825-20 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-825-20) > 20 mL in 1 VIAL, SINGLE-DOSE
DECITABINE decitabine INJECTABLE;INTRAVENOUS 210756 ANDA Lupin Pharmaceuticals, Inc. 68180-738 68180-738-01 1 VIAL in 1 CARTON (68180-738-01) > 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/VIAL
Approval Date:Nov 9, 2018TE:APRLD:No

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