Details for New Drug Application (NDA): 211344
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NDA 211344 describes IBRUTINIB, which is a drug marketed by Zydus Lifesciences and is included in one NDA. Additional details are available on the IBRUTINIB profile page.
The generic ingredient in IBRUTINIB is ibrutinib. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.
The generic ingredient in IBRUTINIB is ibrutinib. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.
Summary for 211344
| Tradename: | IBRUTINIB |
| Applicant: | Zydus Lifesciences |
| Ingredient: | ibrutinib |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 70MG | ||||
| Approval Date: | Mar 31, 2021 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 140MG | ||||
| Approval Date: | Mar 31, 2021 | TE: | RLD: | No | |||||
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