| Tacrolimus Ointment 0.03% Tacrolimus Ointment 0.1% FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE Rx only | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260415 | 8 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Safecor Health LLC | 20260407 | 3 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval:1994 | Stellon Biotech Inc. | CONCORD BIOTECH LIMITED | 20260330 | 2 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES USP safely and effectively. See full prescribing information for TACROLIMUS CAPSULES USP. TACROLIMUS Capsule USP, for oral use Initial U.S. Approval: 1994 Rx only | Jubilant Cadista Pharmaceuticals Inc. | Panacea Biotech Pharma Limited | Panacea Biotec Pharma Limited | 20260316 | 2 |
| TACROLIMUS OINTMENT 0.03% TACROLIMUS OINTMENT 0.1% | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 20260128 | 13 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260121 | 6 |
| These highlights do not include all the information needed to use ASTAGRAF XL ® safely and effectively. See full prescribing information for ASTAGRAF XL. ASTAGRAF XL (tacrolimus extended-release capsules), for oral use Initial U.S. Approval: 1994 | Astellas Pharma US, Inc. | Astellas Ireland Co., Ltd. | Astellas Pharma Inc. | 20260114 | 12 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. Tacrolimus Capsules, for oral use Initial U.S. Approval: 1994 | BPI Labs LLC | AJENAT PHARMACEUTICALS LLC | 20260106 | 12 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES.TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Ajenat Pharmaceuticals LLC | 20251229 | 4 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Ascend Laboratories, LLC | Alkem Laboratories Limited | 20251218 | 26 |
| TACROLIMUS capsules. These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Golden State Medical Supply, Inc. | 20251211 | 13 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES . TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Cardinal Health 107, LLC | 20251205 | 7 |
| These highlights do not include all the information needed to use TACROLIMUS INJECTION safely and effectively. See full prescribing information for TACROLIMUS INJECTION. TACROLIMUS injection, for intravenous use Initial U.S. Approval: 1994 | Nexus Pharmaceuticals, LLC | 20251202 | 11 |
| These highlights do not include all the information needed to use TACROLIMUS EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TACROLIMUS EXTENDED-RELEASE CAPSULES. TACROLIMUS extended-release capsules, for oral use Initial U.S. Approval: 1994 | Amneal Pharmaceuticals NY LLC | 20251020 | 1 |
| Tacrolimus Ointment 0.1% FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE Rx Only Prescribing Information See boxed WARNING concerning long-term safety of topical calcineurin inhibitors | Encube Ethicals, Inc. | Encube Ethicals Private Limited | 20251009 | 4 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Major Pharmaceuticals | 20250922 | 6 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Sandoz Inc. | 20250830 | 22 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Bryant Ranch Prepack | 20250825 | 103 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Mylan Pharmaceuticals Inc. | 20250815 | 22 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Strides Pharma Science Limited | Strides Pharma Global Pte. Ltd. | 20250805 | 19 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | MylanInstitutional Inc. | 20250722 | 18 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | 20250711 | 1 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Bryant Ranch Prepack | 20250703 | 105 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Cardinal Health 107, LLC | 20250604 | 3 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Accord Healthcare Inc. | Intas Pharmaceuticals Limited | 20250602 | 16 |
| These highlights do not include all the information needed to use ENVARSUS XR ® safely and effectively. See full prescribing information for ENVARSUS XR. ENVARSUS XR ® (tacrolimus extended-release tablets), for oral use Initial U.S. Approval: 1994 | Veloxis Pharmaceuticals, Inc | Rottendorf Pharma GmbH | Pharma Packaging Solutions, LLC dba Tjoapack, LLC | 20250226 | 16 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Major Pharmaceuticals | 20250205 | 4 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Quallent Pharmaceuticals Health LLC | Dr. Reddy's Laboratories Limited - FTO3 | 20250130 | 4 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Bryant Ranch Prepack | 20250108 | 105 |
| Tacrus | Pella Pharmaceuticals Co. Ltd | 20241231 | 128 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES USP safely and effectively. See full prescribing information for TACROLIMUS CAPSULES USP. TACROLIMUS Capsules USP, for oral use Initial U.S. Approval: 1994 Rx only | Panacea Biotec Limited | PANACEA BIOTEC PHARMA LIMITED | 20241209 | 14 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | A-S Medication Solutions | 20241021 | 3 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | American Health Packaging | 20241016 | 18 |
| Tacrolimus Ointment, 0.03% and 0.1% FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE | Accord Healthcare Inc. | Intas Pharmaceuticals Limited | 20241004 | 5 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Bryant Ranch Prepack | 20240905 | 104 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Bryant Ranch Prepack | 20240905 | 105 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Bryant Ranch Prepack | 20240905 | 102 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | A-S Medication Solutions | 20240718 | 7 |
| Tacrolimus | Direct_Rx | 20240308 | 3 |
| These highlights do not include all the information needed to use TACROLIMUS EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TACROLIMUS EXTENDED-RELEASE CAPSULES. TACROLIMUS extended-release capsules, for oral use Initial U.S. Approval: 1994 | Chengdu Suncadia Medicine Co., Ltd. | 20240207 | 5 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | NORTHSTAR RX LLC | Glenmark Pharmaceuticals Limited | 20231211 | 3 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval:1994 | CONCORD BIOTECH LIMITED | 20231110 | 5 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Dr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited - FTO3 | 20231101 | 16 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Belcher Pharmaceuticals,LLC | 20231005 | 9 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Proficient Rx LP | 20231001 | 1 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES . TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994 | Biocon Pharma Inc. | Biocon Pharma Limited | Biocon Limited | 20230928 | 12 |
| These highlights do not include all the information needed to use PROGRAF ® safely and effectively. See full prescribing information for PROGRAF. PROGRAF (tacrolimus) capsules, for oral use PROGRAF (tacrolimus) injection, for intravenous use PROGRAF Granules (tacrolimus for oral suspension) Initial U.S. Approval: 1994 | Astellas Pharma US, Inc. | 20230825 | 30 |
| Tacrolimus Ointment 0.03% Ointment 0.1% | Padagis Israel Pharmaceuticals Ltd | LEO Pharma, Inc. | LEO Laboratories Ltd. | 20211115 | 9 |
| HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20% | Sincerus Florida, LLC | 20190516 | 1 |
| NIACINAMIDE 4% / TACROLIMUS 0.03% | Sincerus Florida, LLC | 20190516 | 1 |
| TACROLIMUS 0.1% | Sincerus Florida, LLC | 20190509 | 1 |
| HYALURONIC ACID SODIUM SALT 1% / NIACINAMIDE 4% / TACROLIMUS 0.1% | Sinceru Florida, LLC | Sincerus Florida, LLC | 20190424 | 1 |
| NIACINAMIDE 4% / TACROLIMUS 0.1% | Sincerus Florida, LLC | 20190424 | 1 |
| TACROLIMUS 0.1% IN PSEUDOCATALASE | Sincerus Florida, LLC | 20190424 | 1 |
| These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, USP for oral use Initial U.S. Approval: 1994 | Aphena Pharma Solutions - Tennessee, LLC | 20170503 | 1 |
| These highlights do not include all the information needed to use PROGRAF safely and effectively. See full prescribing information for PROGRAF. PROGRAF ® (tacrolimus) capsules, USP PROGRAF ® (tacrolimus) injection, (for intravenous use) Initial U.S. Approval: 1994 | Aphena Pharma Solutions - Tennessee, LLC | 20140520 | 1 |