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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 212826


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NDA 212826 describes DECITABINE, which is a drug marketed by Accord Hlthcare, Chemi Spa, Cipla, Dr Reddys, Eugia Pharma, Gland, 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 nineteen 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-five suppliers are listed for this compound. Additional details are available on the decitabine profile page.
Summary for 212826
Tradename:DECITABINE
Applicant:Qilu Pharm Hainan
Ingredient:decitabine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212826
Suppliers and Packaging for NDA: 212826
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DECITABINE decitabine INJECTABLE;INTRAVENOUS 212826 ANDA Sagent Pharmaceuticals 25021-219 25021-219-20 1 VIAL in 1 CARTON (25021-219-20) / 20 mL in 1 VIAL
DECITABINE decitabine INJECTABLE;INTRAVENOUS 212826 ANDA Qilu Pharmaceutical Co., Ltd. 67184-0535 67184-0535-1 1 VIAL in 1 CARTON (67184-0535-1) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/VIAL
Approval Date:Apr 12, 2021TE:APRLD:No

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