Details for New Drug Application (NDA): 214264
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NDA 214264 describes TOFACITINIB CITRATE, which is a drug marketed by Hikma, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Biocon Pharma, Dexcel, Sinotherapeutics Inc, Zydus Pharms, and Micro Labs, and is included in ten NDAs. It is available from nine 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. Eleven 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. Eleven 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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