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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 074069


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NDA 074069 describes AZATHIOPRINE, which is a drug marketed by Alkem Labs Ltd, Amneal, Rising, Zydus Pharms Usa, and Hikma, and is included in five NDAs. It is available from ten suppliers. Additional details are available on the AZATHIOPRINE profile page.

The generic ingredient in AZATHIOPRINE is azathioprine sodium. There are sixteen 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 074069
Tradename:AZATHIOPRINE
Applicant:Amneal
Ingredient:azathioprine
Patents:0
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 AvKARE 42291-063 42291-063-01 100 TABLET in 1 BOTTLE (42291-063-01)
AZATHIOPRINE azathioprine TABLET;ORAL 074069 ANDA AvKARE 42291-071 42291-071-01 100 TABLET in 1 BOTTLE (42291-071-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Feb 16, 1996TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Nov 2, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Nov 2, 2021TE:ABRLD:No

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