TOFACITINIB Pharmacologic Class Indexing
- Class set ID
- 3422f4d5-bf2b-4486-b087-1dbd6008ba47
- Version
- 2
- Effective date
- 20180813
- Type
- Indexing - Pharmacologic Class
Mapped DailyMed Labels#
Label, Manufacturer, Effective table| Label | Manufacturer | Effective | SPL version |
|---|
| These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012 | Somerset Therapeutics, LLC | Bluepharma - Industria Farmaceutica, S.a. | 20260602 | 10 |
| These highlights do not include all the information needed to use TOFACITINIB ORAL SOLUTION safely and effectively. See full prescribing information for TOFACITINIB ORAL SOLUTION. TOFACITINIB oral solution Initial U.S. Approval: 2012 | Sun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc. | 20260528 | 2 |
| These highlights do not include all the information needed to use TOFACITINIB EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TOFACITINIB EXTENDED-RELEASE TABLETS. TOFACITINIB extended-release tablets, for oral use Initial U.S. Approval: 2012 | Edenbridge Pharmaceuticals LLC. | 20260526 | 5 |
| These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012 | Apotex Corp. | 20260520 | 2 |
| These highlights do not include all the information needed to use TOFACITINIB EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TOFACITINIB EXTENDED-RELEASE TABLETS. TOFACITINIB extended-release tablets, for oral use Initial U.S. Approval: 2012 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20260512 | 6 |
| TOFACITINIB Extended-Release Tablets | Zydus Lifesciences Limited | 20260512 | 5 |
| These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012 | Breckenridge Pharmaceutical, Inc. | Towa Pharmaceutical Europe, S.L. | 20260507 | 2 |
| These highlights do not include all the information needed to use TOFACITINIB TABLETS safely and effectively. See full prescribing information for TOFACITINIB TABLETS. TOFACITINIB tablets, for oral use Initial U.S. Approval: 2012 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20260505 | 6 |
| TOFACITINIB tablets, for oral use | Zydus Lifesciences Limited | 20260505 | 4 |
| These highlights do not include all the information needed to use TOFACITINIB EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TOFACITINIB EXTENDED-RELEASE TABLETS. TOFACITINIB extended-release tablets, for oral use Initial U.S. Approval: 2012 | Biocon Pharma Inc | Biocon Pharma Limited | 20260409 | 10 |
| These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012 | U.S. Pharmaceuticals | Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pfizer Asia Manufacturing Pte Ltd | Pharmacia & Upjohn Company LLC | 20260327 | 17 |
| These highlights do not include all the information needed to use TOFACITINIB EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TOFACITINIB EXTENDED-RELEASE TABLETS. TOFACITINIB extended-release tablets, for oral use Initial U.S. Approval: 2012 | Aurobindo Pharma Limited | 20260312 | 7 |
| These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR. XELJANZ ® (tofacitinib) tablets, for oral use XELJANZ ® (tofacitinib) oral solution XELJANZ ® XR (tofacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2012 | Pfizer Laboratories Div Pfizer Inc | Viatris Pharmaceuticals LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Deutschland GmbH | Pharmacia & Upjohn Company LLC | Pfizer Asia Manufacturing Pte Ltd | 20260312 | 53 |
| These highlights do not include all the information needed to use TOFACITINIB EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TOFACITINIB EXTENDED-RELEASE TABLETS. TOFACITINIB extended-release tablets, for oral use Initial U.S. Approval: 2012 | Ajanta Pharma USA Inc. | Ajanta Pharma Limited, Paithan | 20260125 | 5 |