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Details for New Drug Application (NDA): 207518

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NDA 207518 describes AZACITIDINE, which is a drug marketed by Actavis Llc, Shilpa Medicare, Dr Reddys Labs Ltd, and Mylan Institutional, and is included in four NDAs. It is available from four suppliers. Additional details are available on the AZACITIDINE profile page.

The generic ingredient in AZACITIDINE is azacitidine. There are thirteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the azacitidine profile page.

Summary for NDA: 207518

Tradename:
AZACITIDINE
Applicant:
Shilpa Medicare
Ingredient:
azacitidine
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 207518

Suppliers and Packaging for NDA: 207518

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZACITIDINE
azacitidine
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 207518 ANDA Wockhardt USA LLC. 64679-096 64679-096-01 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (64679-096-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength100MG/VIAL
Approval Date:Sep 29, 2016TE:APRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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