Details for New Drug Application (NDA): 214264
NDA 214264 describes TOFACITINIB CITRATE, which is a drug marketed by Hikma, MSN, Pharmaco, Saptalis Pharms, Sun Pharm Inds Inc, Ajanta Pharma Ltd, Apotex, Aurobindo Pharma Ltd, Biocon Pharma, Dexcel, Orient Pharma, Sciegen Pharms, Sinotherapeutics Inc, Teva Pharms Usa, Zydus Pharms, Breckenridge, Concord Biotech Ltd, Macleods Pharms, Micro Labs, Somerset Theraps Llc, Specgx Llc, and Yaopharma Co Ltd, and is included in twenty-seven NDAs. It is available from twenty-six suppliers. Additional details are available on the TOFACITINIB CITRATE profile page.
The generic ingredient in TOFACITINIB CITRATE is tofacitinib citrate. There is one drug master file entry for this compound. Twenty-eight 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 is one drug master file entry for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.
Summary for 214264
| Tradename: | TOFACITINIB CITRATE |
| Applicant: | Zydus Pharms |
| Ingredient: | tofacitinib citrate |
| Patents: | 0 |
Pharmacology for NDA: 214264
| Mechanism of Action | Janus Kinase Inhibitors |
Suppliers and Packaging for NDA: 214264
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOFACITINIB CITRATE | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 214264 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1353 | 70710-1353-3 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1353-3) |
| TOFACITINIB CITRATE | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 214264 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1353 | 70710-1353-9 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1353-9) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 11MG BASE | ||||
| Approval Date: | Aug 19, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 22MG BASE | ||||
| Approval Date: | Aug 19, 2021 | TE: | AB | RLD: | No | ||||
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