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Last Updated: May 28, 2020

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Details for New Drug Application (NDA): 077621


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NDA 077621 describes AZATHIOPRINE, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms Llc, Mylan, Zydus Pharms Usa, and West-ward Pharms Int, and is included in five NDAs. It is available from seven 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 077621
Tradename:AZATHIOPRINE
Applicant:Zydus Pharms Usa
Ingredient:azathioprine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077621
Suppliers and Packaging for NDA: 077621
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZATHIOPRINE azathioprine TABLET;ORAL 077621 ANDA Cadila Healthcare Limited 65841-602 65841-602-01 100 TABLET in 1 BOTTLE (65841-602-01)
AZATHIOPRINE azathioprine TABLET;ORAL 077621 ANDA Cadila Healthcare Limited 65841-602 65841-602-05 500 TABLET in 1 BOTTLE (65841-602-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 15, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 5, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Sep 5, 2008TE:ABRLD:No

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