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Generated: May 25, 2017

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Details for New Drug Application (NDA): 074069

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NDA 074069 describes AZATHIOPRINE, which is a drug marketed by Zydus Pharms Usa, Mylan, Amneal Pharms Llc, and West-ward Pharms Int, and is included in four NDAs. It is available from fifteen suppliers. Additional details are available on the AZATHIOPRINE profile page.

The generic ingredient in AZATHIOPRINE is azathioprine sodium. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the azathioprine sodium profile page.

Summary for NDA: 074069

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 074069

Suppliers and Packaging for NDA: 074069

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZATHIOPRINE
azathioprine
TABLET;ORAL 074069 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7568 0615-7568-39 30 TABLET in 1 BLISTER PACK (0615-7568-39)
AZATHIOPRINE
azathioprine
TABLET;ORAL 074069 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-686 43353-686-09 9000 TABLET in 1 BOTTLE, PLASTIC (43353-686-09)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Feb 16, 1996TE:ABRLD: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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