Details for New Drug Application (NDA): 074069
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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
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 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: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Feb 16, 1996 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
Approval Date: | Nov 2, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Nov 2, 2021 | TE: | AB | RLD: | No |
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