Details for New Drug Application (NDA): 216878
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NDA 216878 describes TOFACITINIB CITRATE, which is a drug marketed by Hikma, Ajanta Pharma Ltd, Micro Labs, and Zydus Pharms, and is included in four NDAs. Additional details are available on the TOFACITINIB CITRATE profile page.
The generic ingredient in TOFACITINIB CITRATE is tofacitinib citrate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.
The generic ingredient in TOFACITINIB CITRATE is tofacitinib citrate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.
Summary for 216878
| Tradename: | TOFACITINIB CITRATE |
| Applicant: | Hikma |
| Ingredient: | tofacitinib citrate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | EQ 1MG BASE/ML | ||||
| Approval Date: | Sep 25, 2023 | TE: | RLD: | No | |||||
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