Details for New Drug Application (NDA): 209829
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NDA 209829 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 209829
| Tradename: | TOFACITINIB CITRATE |
| Applicant: | Zydus Pharms |
| Ingredient: | tofacitinib citrate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Mar 13, 2023 | TE: | RLD: | No | |||||
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