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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 206033


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NDA 206033 describes DECITABINE, which is a drug marketed by Accord Hlthcare, Chemi Spa, Cipla, Dr Reddys, Eugia Pharma, Gland, Hetero Labs Ltd Vi, Jiangsu Hansoh Pharm, Lupin Ltd, Meitheal, MSN, Nivagen Pharms Inc, Novast Labs, Pharmascience Inc, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Wockhardt Bio Ag, Zydus Pharms, and Sun Pharm, and is included in twenty NDAs. It is available from twenty-four 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. Twenty-four suppliers are listed for this compound. Additional details are available on the decitabine profile page.
Summary for 206033
Tradename:DECITABINE
Applicant:Chemi Spa
Ingredient:decitabine
Patents:0
Pharmacology for NDA: 206033
Suppliers and Packaging for NDA: 206033
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DECITABINE decitabine INJECTABLE;INTRAVENOUS 206033 ANDA Amneal Pharmaceuticals LLC 70121-1644 70121-1644-1 1 VIAL, SINGLE-USE in 1 CARTON (70121-1644-1) / 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/VIAL
Approval Date:Sep 22, 2017TE:APRLD:No

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