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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 207234


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NDA 207234 describes AZACITIDINE, which is a drug marketed by Accord Hlthcare, Actavis Llc, Amneal, Cipla, Dr Reddys, Eugia Pharma, Eurohlth Intl Sarl, Jiangsu Hansoh Pharm, Lupin Ltd, Meitheal, Mylan Institutional, Natco Pharma Ltd, and Shilpa Medicare, and is included in thirteen NDAs. It is available from sixteen suppliers. Additional details are available on the AZACITIDINE profile page.

The generic ingredient in AZACITIDINE is azacitidine. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the azacitidine profile page.
Summary for 207234
Tradename:AZACITIDINE
Applicant:Natco Pharma Ltd
Ingredient:azacitidine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207234
Medical Subject Heading (MeSH) Categories for 207234
Suppliers and Packaging for NDA: 207234
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 207234 ANDA Dr. Reddy's Laboratories Inc. 43598-143 43598-143-62 1 mL in 1 CARTON (43598-143-62)
AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 207234 ANDA Panacea Biotec Limited 43817-906 43817-906-01 1 VIAL, SINGLE-DOSE in 1 CARTON (43817-906-01) / 50 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUS, SUBCUTANEOUSStrength100MG/VIAL
Approval Date:Jun 23, 2017TE:APRLD:No

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