Details for New Drug Application (NDA): 208687
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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 208687
Tradename: | AZATHIOPRINE |
Applicant: | Alkem Labs Ltd |
Ingredient: | azathioprine |
Patents: | 0 |
Pharmacology for NDA: 208687
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 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: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Mar 27, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 27, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
Approval Date: | Mar 27, 2020 | TE: | AB | RLD: | No |
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