Suppliers and packagers for TOFACITINIB CITRATE
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TOFACITINIB CITRATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hikma | TOFACITINIB CITRATE | tofacitinib citrate | SOLUTION;ORAL | 216878 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0821-58 | 1 BOTTLE in 1 CARTON (0054-0821-58) / 240 mL in 1 BOTTLE | 2026-06-03 |
| Ajanta Pharma Ltd | TOFACITINIB CITRATE | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 219542 | ANDA | Ajanta Pharma USA Inc. | 27241-270-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-270-30) | 2026-06-03 |
| Aurobindo Pharma Ltd | TOFACITINIB CITRATE | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 218462 | ANDA | Aurobindo Pharma Limited | 59651-685-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-685-30) | 2026-06-03 |
| Biocon Pharma | TOFACITINIB CITRATE | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 219442 | ANDA | Biocon Pharma Inc | 70377-057-11 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70377-057-11) | 2026-06-03 |
| Dexcel | TOFACITINIB CITRATE | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 218668 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-970-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42799-970-30) | 2026-06-03 |
| Sinotherapeutics Inc | TOFACITINIB CITRATE | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 216001 | ANDA | Padagis US LLC | 0574-1811-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0574-1811-30) | 2026-06-15 |
| Zydus Pharms | TOFACITINIB CITRATE | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 214264 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1353-3 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1353-3) | 2026-05-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
