Details for New Drug Application (NDA): 077621
✉ Email this page to a colleague
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 |
Pharmacology for NDA: 077621
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 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 | Zydus Lifesciences Limited | 65841-602 | 65841-602-01 | 100 TABLET in 1 BOTTLE (65841-602-01) |
AZATHIOPRINE | azathioprine | TABLET;ORAL | 077621 | ANDA | Zydus Lifesciences Limited | 65841-602 | 65841-602-05 | 500 TABLET in 1 BOTTLE (65841-602-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 15, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Sep 5, 2008 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
Approval Date: | Sep 5, 2008 | TE: | AB | RLD: | No |
Complete Access Available with Subscription