Details for New Drug Application (NDA): 216001
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NDA 216001 describes TOFACITINIB CITRATE, which is a drug marketed by Auson, Hikma, MSN, Saptalis Pharms, Sun Pharm Inds Inc, Ajanta Pharma Ltd, Apotex, Aurobindo Pharma Ltd, Biocon Pharma, Dexcel, Orient Pharma, Sinotherapeutics Inc, Zydus Pharms, Breckenridge, Concord Biotech Ltd, Macleods Pharms Ltd, Micro Labs, Somerset Theraps Llc, Specgx Llc, and Yaopharma Co Ltd, and is included in twenty-five NDAs. It is available from nineteen suppliers. 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. Twenty-one 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. Twenty-one suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.
Summary for 216001
| Tradename: | TOFACITINIB CITRATE |
| Applicant: | Sinotherapeutics Inc |
| Ingredient: | tofacitinib citrate |
| Patents: | 0 |
Pharmacology for NDA: 216001
| Mechanism of Action | Janus Kinase Inhibitors |
Suppliers and Packaging for NDA: 216001
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOFACITINIB CITRATE | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 216001 | ANDA | Padagis US LLC | 0574-1811 | 0574-1811-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0574-1811-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 11MG BASE | ||||
| Approval Date: | Sep 30, 2025 | TE: | AB | RLD: | No | ||||
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