| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | REMEDYREPACK INC. | 20260429 | 2 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Marlex Pharmaceuticals, Inc. | 20260323 | 4 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS . VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Par Health USA, LLC | 20260210 | 23 |
| These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006 | Pfizer Laboratories Div Pfizer Inc | Pfizer Inc | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Italia S.r.l. | Pfizer Manufacturing Deutschland GmbH | 20260123 | 49 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Umedica Laboratories USA Inc. | Umedica Laboratories Pvt. Ltd. | 20260121 | 2 |
| Varenicline Tablets These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. Initial U.S. Approval: 2006 | AvKARE | 20260119 | 2 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Glenmark Pharmaceuticals Inc., USA | Mankind Pharma Limited | 20260107 | 8 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | American Health Packaging | 20251210 | 4 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | American Health Packaging | 20251210 | 3 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE Tablets, for oral use Initial U.S. Approval: 2006 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251203 | 14 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Ajanta Pharma USA Inc. | Ajanta Pharma Limited, Paithan | 20251130 | 6 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Micro Labs Limited | 20251031 | 1 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Kanchan Healthcare Inc | Medley Pharmaceuticals Limited | 20251014 | 1 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Macleods Pharmaceuticals Limited | 20250918 | 3 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Nivagen Pharmaceuticals Inc. | Piramal Pharma Limited | 20250831 | 1 |
| VARENICLINE TABLETS. These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Golden State Medical Supply, Inc. | 20250602 | 3 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20250508 | 1 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS . VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Dr. Reddys Laboratories Inc. | Dr. Reddy's Laboratories Limited | 20250425 | 6 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Apotex Corp | 20250410 | 5 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Leading Pharma, LLC | Medley Pharmaceuticals Limited | 20241128 | 7 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Florida Pharmaceutical Products, LLC | INDOCO REMEDIES LIMITED | 20241105 | 1 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Indoco Remedies Limited | 20241104 | 3 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | NorthStar RxLLC | Hetero Labs Limited Unit III | 20240927 | 1 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Bryant Ranch Prepack | 20240716 | 102 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | A-S Medication Solutions | 20240614 | 4 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | A-S Medication Solutions | 20240429 | 2 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Bryant Ranch Prepack | 20240402 | 101 |
| These highlights do not include all the information needed to use TYRVAYA safely and effectively. See full prescribing information for TYRVAYA. TYRVAYA ® (varenicline solution) nasal spray Initial U.S. Approval: 2006 | Oyster Point Pharma, Inc. | 20240212 | 14 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Zydus Pharmaceuticals USA Inc. | Zydus Worldwide DMCC | Zydus Lifesciences Limited | 20240210 | 3 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Major Pharmaceuticals | Alkem Laboratories Limited | 20231215 | 1 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Camber Pharmaceuticals, Inc. | Hetero Labs Limited Unit III | 20231108 | 1 |
| Varenicline Tablets | Zydus Lifesciences Limited | 20230928 | 2 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Ascend Laboratories, LLC | Alkem Laboratories Limited | 20230927 | 7 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | A-S Medication Solutions | 20230430 | 1 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | A-S Medication Solutions | 20230425 | 1 |
| These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS . VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | Mylan Pharmaceuticals Inc. | 20230415 | 3 |
| These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006 | A-S Medication Solutions | 20210415 | 3 |
| These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006 | A-S Medication Solutions | 20210326 | 6 |
| These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006 | A-S Medication Solutions | 20210223 | 10 |
| These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) Tablets Initial U.S. Approval: 2006 | Proficient Rx LP | 20200201 | 4 |
| These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006 | Proficient Rx LP | 20200101 | 1 |
| These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006 | A-S Medication Solutions | 20191003 | 2 |
| These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006 | Aphena Pharma Solutions - Tennessee, LLC | 20171218 | 1 |
| These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006 | Avera McKennan Hospital | 20170315 | 1 |
| These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX® (varenicline) Tablets Initial U.S. Approval: 2006 | Carilion Materials Management | 20140603 | 2 |
| These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX® (varenicline) Tablets Initial U.S. Approval: 2006 | Carilion Materials Management | 20140603 | 2 |
| These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX® (varenicline) Tablets Initial U.S. Approval: 2006 | Physicians Total Care, Inc. | Pfizer Ireland Pharmaceuticals | Pfizer Manufacturing Deutschland GmbH | Pfizer Pharmaceuticals LLC | 20111219 | 2 |
| These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX® (varenicline) Tablets Initial U.S. Approval: 2006 | Rebel Distributors Corp | 20110720 | 1 |
| These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX® (varenicline) Tablets Initial U.S. Approval: 2006 | Rebel Distributors Corp | 20100923 | 1 |