| 0069-0468 | CHANTIX | varenicline tartrate | Pfizer Laboratories Div Pfizer Inc | NDA |
| 0069-0469 | CHANTIX | varenicline tartrate | Pfizer Laboratories Div Pfizer Inc | NDA |
| 0069-0471 | CHANTIX | varenicline tartrate | Pfizer Laboratories Div Pfizer Inc | NDA |
| 0378-5090 | Varenicline | Varenicline | Mylan Pharmaceuticals Inc. | ANDA |
| 0904-7413 | varenicline | varenicline tartrate | Major Pharmaceuticals | ANDA |
| 0904-7414 | varenicline | varenicline tartrate | Major Pharmaceuticals | ANDA |
| 0904-7415 | Varenicline | Varenicline tartrate | Major Pharmaceuticals | ANDA |
| 10135-808 | Varenicline | Varenicline tartrate | Marlex Pharmaceuticals, Inc. | ANDA |
| 10135-809 | Varenicline | Varenicline tartrate | Marlex Pharmaceuticals, Inc. | ANDA |
| 14445-153 | Varenicline tartrate | Varenicline tartrate | Indoco Remedies Limited | ANDA |
| 14445-154 | Varenicline tartrate | Varenicline tartrate | Indoco Remedies Limited | ANDA |
| 14445-155 | Varenicline | Varenicline Tartrate | Indoco Remedies Limited | ANDA |
| 27241-173 | Varenicline | Varenicline tartrate | Ajanta Pharma USA Inc. | ANDA |
| 27241-174 | Varenicline | Varenicline tartrate | Ajanta Pharma USA Inc. | ANDA |
| 27241-187 | Varenicline | Varenicline tartrate | Ajanta Pharma USA Inc. | ANDA |
| 31722-678 | Varenicline | Varenicline tartrate | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-679 | Varenicline | Varenicline tartrate | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-690 | Varenicline | Varenicline tartrate | Camber Pharmaceuticals, Inc. | ANDA |
| 33342-489 | Varenicline | Varenicline | Macleods Pharmaceuticals Limited | ANDA |
| 33342-490 | Varenicline | Varenicline | Macleods Pharmaceuticals Limited | ANDA |
| 42291-927 | varenicline | varenicline tartrate | AvKARE | ANDA |
| 42291-928 | varenicline | varenicline tartrate | AvKARE | ANDA |
| 42291-929 | Varenicline | Varenicline tartrate | AvKARE | ANDA |
| 42571-459 | varenicline tartrate | varenicline tartrate | Micro Labs Limited | ANDA |
| 42571-460 | varenicline tartrate | varenicline tartrate | Micro Labs Limited | ANDA |
| 42571-475 | Varenicline tartrate | Varenicline tartrate | Micro Labs Limited | ANDA |
| 43353-899 | CHANTIX | varenicline tartrate | Aphena Pharma Solutions - Tennessee, LLC | NDA |
| 43598-022 | varenicline tartrate | varenicline tartrate | Dr. Reddys Laboratories Inc. | ANDA |
| 43598-023 | varenicline tartrate | varenicline tartrate | Dr. Reddys Laboratories Inc. | ANDA |
| 43598-907 | varenicline tartrate | varenicline tartrate | Dr. Reddys Laboratories Inc. | ANDA |
| 43598-908 | varenicline tartrate | varenicline tartrate | Dr. Reddys Laboratories Inc. | ANDA |
| 49884-155 | Varenicline | varenicline tartrate | Par Health USA, LLC | ANDA |
| 49884-156 | Varenicline | varenicline tartrate | Par Health USA, LLC | ANDA |
| 49884-944 | Varenicline | varenicline tartrate | Par Health USA, LLC | ANDA |
| 50090-6446 | VARENICLINE | VARENICLINE | A-S Medication Solutions | ANDA |
| 50090-6447 | VARENICLINE | VARENICLINE | A-S Medication Solutions | ANDA |
| 50090-7135 | varenicline | varenicline tartrate | A-S Medication Solutions | ANDA |
| 50090-7182 | varenicline | varenicline tartrate | A-S Medication Solutions | ANDA |
| 51407-755 | VARENICLINE | VARENICLINE | Golden State Medical Supply, Inc. | ANDA |
| 51407-756 | VARENICLINE | VARENICLINE | Golden State Medical Supply, Inc. | ANDA |
| 59651-417 | Varenicline | Varenicline | Aurobindo Pharma Limited | ANDA |
| 59651-418 | Varenicline | Varenicline | Aurobindo Pharma Limited | ANDA |
| 60290-077 | VARENICLINE | VARENICLINE | Umedica Laboratories USA Inc. | ANDA |
| 60290-078 | VARENICLINE | VARENICLINE | Umedica Laboratories USA Inc. | ANDA |
| 60505-3613 | VARENICLINE | VARENICLINE | Apotex Corp | ANDA |
| 60505-3614 | VARENICLINE | VARENICLINE | Apotex Corp | ANDA |
| 60505-4794 | VARENICLINE | VARENICLINE | Apotex Corp | ANDA |
| 60505-4795 | VARENICLINE | VARENICLINE | Apotex Corp | ANDA |
| 60687-648 | Varenicline | varenicline tartrate | American Health Packaging | ANDA |
| 60687-893 | Varenicline | Varenicline tartrate | American Health Packaging | ANDA |
| 63187-618 | CHANTIX | varenicline tartrate | Proficient Rx LP | NDA |
| 67877-743 | varenicline | varenicline tartrate | Ascend Laboratories, LLC | ANDA |
| 67877-744 | varenicline | varenicline tartrate | Ascend Laboratories, LLC | ANDA |
| 67877-745 | Varenicline | Varenicline tartrate | Ascend Laboratories, LLC | ANDA |
| 68462-893 | varenicline tartrate | varenicline tartrate | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-894 | varenicline tartrate | varenicline tartrate | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-895 | varenicline tartrate | varenicline tartrate | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 69315-402 | VARENICLINE TARTRATE | VARENICLINE TARTRATE | Leading Pharma, LLC | ANDA |
| 69315-403 | VARENICLINE TARTRATE | VARENICLINE TARTRATE | Leading Pharma, LLC | ANDA |
| 69315-404 | VARENICLINE TARTRATE | VARENICLINE TARTRATE | Leading Pharma, LLC | ANDA |
| 70518-4647 | Varenicline | Varenicline tartrate | REMEDYREPACK INC. | ANDA |
| 70710-1613 | Varenicline | Varenicline | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1614 | Varenicline | Varenicline | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70748-125 | VARENICLINE TARTRATE | VARENICLINE TARTRATE | Lupin Pharmaceuticals, Inc. | ANDA |
| 70748-127 | VARENICLINE | VARENICLINE | Lupin Pharmaceuticals, Inc. | ANDA |
| 70748-128 | VARENICLINE | VARENICLINE | Lupin Pharmaceuticals, Inc. | ANDA |
| 70771-1773 | Varenicline | Varenicline | Zydus Lifesciences Limited | ANDA |
| 70771-1774 | Varenicline | Varenicline | Zydus Lifesciences Limited | ANDA |
| 71205-381 | CHANTIX | varenicline tartrate | Proficient Rx LP | NDA |
| 71921-307 | Varenicline | Varenicline Tartrate | Florida Pharmaceutical Products, LLC | ANDA |
| 71921-308 | Varenicline tartrate | Varenicline tartrate | Florida Pharmaceutical Products, LLC | ANDA |
| 71921-309 | Varenicline tartrate | Varenicline tartrate | Florida Pharmaceutical Products, LLC | ANDA |
| 72162-2218 | VARENICLINE | VARENICLINE | Bryant Ranch Prepack | ANDA |
| 72162-2219 | VARENICLINE | VARENICLINE | Bryant Ranch Prepack | ANDA |
| 72603-476 | Varenicline | Varenicline tartrate | NorthStar RxLLC | ANDA |
| 72603-477 | Varenicline | Varenicline tartrate | NorthStar RxLLC | ANDA |
| 72603-478 | Varenicline | Varenicline tartrate | NorthStar RxLLC | ANDA |
| 73521-030 | Tyrvaya | varenicline | Oyster Point Pharma, Inc. | NDA |
| 75834-334 | varenicline | varenicline | Nivagen Pharmaceuticals Inc. | ANDA |
| 75834-335 | varenicline | varenicline | Nivagen Pharmaceuticals Inc. | ANDA |
| 21695-633 | Chantix | varenicline tartrate | Rebel Distributors Corp | NDA |
| 21695-945 | CHANTIX | varenicline tartrate | Rebel Distributors Corp | NDA |
| 21695-946 | Chantix | varenicline tartrate | Rebel Distributors Corp | NDA |
| 50090-0995 | CHANTIX | varenicline tartrate | A-S Medication Solutions | NDA |
| 50090-0998 | CHANTIX | varenicline tartrate | A-S Medication Solutions | NDA |
| 50090-3528 | CHANTIX | varenicline tartrate | A-S Medication Solutions | NDA |
| 50090-4481 | CHANTIX | varenicline tartrate | A-S Medication Solutions | NDA |
| 50090-4482 | CHANTIX | varenicline tartrate | A-S Medication Solutions | NDA |
| 60505-4765 | APO-VARENICLINE | VARENICLINE | Apotex Corp | UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE |
| 60505-4766 | APO-VARENICLINE | VARENICLINE | Apotex Corp | UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE |
| 63539-473 | CHANTIX | varenicline tartrate | U.S. Pharmaceuticals | NDA |
| 68151-4952 | CHANTIX | varenicline tartrate | Carilion Materials Management | NDA |
| 68151-4953 | CHANTIX | varenicline tartrate | Carilion Materials Management | NDA |
| 69189-0492 | CHANTIX | varenicline tartrate | Avera McKennan Hospital | NDA |