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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 208687


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NDA 208687 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 nine 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 208687
Tradename:AZATHIOPRINE
Applicant:Alkem Labs Ltd
Ingredient:azathioprine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208687
Suppliers and Packaging for NDA: 208687
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZATHIOPRINE azathioprine TABLET;ORAL 208687 ANDA Ascend Laboratories, LLC 67877-492 67877-492-01 100 TABLET in 1 BOTTLE (67877-492-01)
AZATHIOPRINE azathioprine TABLET;ORAL 208687 ANDA Ascend Laboratories, LLC 67877-492 67877-492-05 500 TABLET in 1 BOTTLE (67877-492-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Mar 27, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 27, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Mar 27, 2020TE:ABRLD:No

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