Details for New Drug Application (NDA): 016324
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NDA 016324 describes IMURAN, which is a drug marketed by Casper Pharma Llc and Sebela Ireland Ltd and is included in two NDAs. It is available from one supplier. Additional details are available on the IMURAN profile page.
The generic ingredient in IMURAN is azathioprine. There are sixteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the azathioprine profile page.
The generic ingredient in IMURAN is azathioprine. There are sixteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the azathioprine profile page.
Summary for 016324
| Tradename: | IMURAN |
| Applicant: | Sebela Ireland Ltd |
| Ingredient: | azathioprine |
| Patents: | 0 |
Pharmacology for NDA: 016324
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 016324
Suppliers and Packaging for NDA: 016324
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IMURAN | azathioprine | TABLET;ORAL | 016324 | NDA | Sebela Pharmaceuticals Inc. | 54766-590 | 54766-590-10 | 100 TABLET in 1 BOTTLE (54766-590-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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