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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 050794


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NDA 050794 describes VIDAZA, which is a drug marketed by Bristol-myers and is included in one NDA. It is available from two suppliers. Additional details are available on the VIDAZA profile page.

The generic ingredient in VIDAZA 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 050794
Tradename:VIDAZA
Applicant:Bristol-myers
Ingredient:azacitidine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050794
Medical Subject Heading (MeSH) Categories for 050794
Suppliers and Packaging for NDA: 050794
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIDAZA azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 050794 NDA AUTHORIZED GENERIC Sandoz Inc 0781-3253 0781-3253-94 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0781-3253-94)
VIDAZA azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 050794 NDA AUTHORIZED GENERIC Sandoz Inc 0781-9253 0781-9253-94 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0781-9253-94)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUS, SUBCUTANEOUSStrength100MG/VIAL
Approval Date:May 19, 2004TE:APRLD:Yes
Regulatory Exclusivity Expiration:May 20, 2025
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS AGED ONE MONTH AND OLDER WITH NEWLY DIAGNOSED JUVENILE MYELOMONOCYTIC LEUKEMIA (JMML)
Regulatory Exclusivity Expiration:May 20, 2029
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS AGED ONE MONTH AND OLDER WITH NEWLY DIAGNOSED JUVENILE MYELOMONOCYTIC LEUKEMIA (JMML)

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