Details for New Drug Application (NDA): 209829
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NDA 209829 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 209829
| Tradename: | TOFACITINIB CITRATE |
| Applicant: | Zydus Pharms |
| Ingredient: | tofacitinib citrate |
| Patents: | 0 |
Pharmacology for NDA: 209829
| Mechanism of Action | Janus Kinase Inhibitors |
Suppliers and Packaging for NDA: 209829
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 209829 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1243 | 70710-1243-6 | 60 TABLET, FILM COATED in 1 BOTTLE (70710-1243-6) |
| TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 209829 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1243 | 70710-1243-8 | 180 TABLET, FILM COATED in 1 BOTTLE (70710-1243-8) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Mar 13, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Jun 5, 2026 | TE: | AB | RLD: | No | ||||
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