Details for New Drug Application (NDA): 215893
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NDA 215893 describes PONATINIB HYDROCHLORIDE, which is a drug marketed by Apotex and is included in one NDA. Additional details are available on the PONATINIB HYDROCHLORIDE profile page.
The generic ingredient in PONATINIB HYDROCHLORIDE is ponatinib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.
The generic ingredient in PONATINIB HYDROCHLORIDE is ponatinib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.
Summary for 215893
| Tradename: | PONATINIB HYDROCHLORIDE |
| Applicant: | Apotex |
| Ingredient: | ponatinib hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 15MG BASE | ||||
| Approval Date: | Jul 14, 2023 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 45MG BASE | ||||
| Approval Date: | Jul 14, 2023 | TE: | RLD: | No | |||||
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