| These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989 | A-S Medication Solutions | 20260303 | 12 |
| These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989 | Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited | 20260206 | 17 |
| These highlights do not include all the information needed to use Tri-Estarylla safely and effectively. See full prescribing information for Tri-Estarylla. Tri-Estarylla ® (norgestimate and ethinyl estradiol, USP) tablets, for oral use Initial U.S. Approval: 1989 | A-S Medication Solutions | 20260127 | 3 |
| These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE AND ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 1989 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251209 | 10 |
| These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP. NORGESTIMATE and ETHINYL ESTRADIOL tablets USP, for oral use Initial U.S. Approval: 1989 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251209 | 8 |
| These highlights do not include all the information needed to use TRI-LO-MARZIA safely and effectively. See full prescribing information for TRI-LO-MARZIA. TRI-LO-MARZIA™ (norgestimate and ethinyl estradiol tablets USP), for oral use Initial U.S. Approval: 1989 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20251209 | 14 |
| These highlights do not include all the information needed to use Tri-Linyah safely and effectively. See full prescribing information for Tri-Linyah. Tri-Linyah (norgestimate/ethinyl estradiol) tablets, for oral use. Initial U.S. Approval: 1989 | Northstar Rx LLC | Novast Laboratories, Ltd. | 20251205 | 11 |
| These highlights do not include all the information needed to use TRI-SPRINTEC ® safely and effectively. See full prescribing information for TRI-SPRINTEC ® . TRI-SPRINTEC ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Preferred Pharmaceuticals Inc. | 20251001 | 8 |
| These highlights do not include all the information needed to use SPRINTEC safely and effectively. See full prescribing information for SPRINTEC. SPRINTEC ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Preferred Pharmaceuticals, Inc. | 20250924 | 8 |
| These highlights do not include all the information needed to use SPRINTEC safely and effectively. See full prescribing information for SPRINTEC. SPRINTEC ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | PD-Rx Pharmaceuticals, Inc. | 20250408 | 8 |
| These highlights do not include all the information needed to use TRI-LO-MARZIA safely and effectively. See full prescribing information for TRI-LO-MARZIA. TRI-LO-MARZIA™ (norgestimate and ethinyl estradiol tablets USP), for oral use Initial U.S. Approval: 1989 | PD-Rx Pharmaceuticals, Inc. | 20250408 | 15 |
| These highlights do not include all the information needed to use TRI-SPRINTEC ® safely and effectively. See full prescribing information for TRI-SPRINTEC ® . TRI-SPRINTEC ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Teva Pharmaceuticals USA, Inc. | 20250312 | 17 |
| These highlights do not include all the information needed to use Mono-Linyah safely and effectively. See full prescribing information for Mono-Linyah. Mono-Linyah (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval:1989 | Northstar Rx LLC | Novast Laboratories, Ltd. | 20250120 | 9 |
| These highlights do not include all the information needed to use VyLibra safely and effectively. See full prescribing information for VyLibra. VyLibra ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Afaxys Pharma, LLC | Aurobindo Pharma Limited | 20250104 | 8 |
| These highlights do not include all the information needed to use SPRINTEC safely and effectively. See full prescribing information for SPRINTEC. SPRINTEC ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Teva Pharmaceuticals USA, Inc. | 20241219 | 13 |
| These highlights do not include all the information needed to use MILI safely and effectively. See full prescribing information for MILI. MILI ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Aurobindo Pharma Limited | 20241207 | 12 |
| These highlights do not include all the information needed to use Estarylla safely and effectively. See full prescribing information for Estarylla. Estarylla ® (NORGESTIMATE and ETHINYL ESTRADIOL tablets) for oral use Initial U.S. Approval: 1989 | Proficient Rx LP | 20241001 | 1 |
| These highlights do not include all the information needed to use Estarylla™ safely and effectively. See full prescribing information for Estarylla™. Estarylla™ (NORGESTIMATE and ETHINYL ESTRADIOL tablets) for oral use Initial U.S. Approval: 1989 | Bryant Ranch Prepack | 20240924 | 104 |
| These highlights do not include all the information needed to use SPRINTEC safely and effectively. See full prescribing information for SPRINTEC. SPRINTEC ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | RedPharm Drug | 20240711 | 1 |
| These highlights do not include all the information needed to use Tri-Estarylla safely and effectively. See full prescribing information for Tri-Estarylla. Tri-Estarylla ® (norgestimate and ethinyl estradiol, USP) tablets, for oral use Initial U.S. Approval: 1989 | Bryant Ranch Prepack | 20240521 | 104 |
| These highlights do not include all the information needed to use Tri-Lo-Estarylla safely and effectively. See full prescribing information for Tri-Lo-Estarylla. Tri-Lo-Estarylla ® (norgestimate and ethinyl estradiol tablets) for oral use Initial U.S. Approval: 1989 | Bryant Ranch Prepack | 20240521 | 104 |
| These highlights do not include all the information needed to use Mono-Linyah safely and effectively. See full prescribing information for Mono-Linyah. Mono-Linyah (norgestimate/ethinyl estradiol tablets) for oral use. Initial U.S. Approval:1989 | A-S Medication Solutions | 20240507 | 6 |
| NORGESTIMATE and ETHINYL ESTRADIOL tablets USP These highlights do not include all the information needed to use NORGESTIMATE and ETHINYL ESTRADIOL TABLETS USP safely and effectively. See full prescribing information for NORGESTIMATE and ETHINYL ESTRADIOL TABLETS USP. NORGESTIMATE and ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 1989 | Naari Pte Limited | Naari Pharma Private Limited | 20240423 | 5 |
| These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP. NORGESTIMATE and ETHINYL ESTRADIOL tablets USP, for oral use Initial U.S. Approval: 1989 | Naari Pte Limited | 20240423 | 5 |
| These highlights do not include all the information needed to use TRI-LO-MARZIA safely and effectively. See full prescribing information for TRI-LO-MARZIA. TRI-LO-MARZIA™ (norgestimate and ethinyl estradiol tablets USP), for oral use Initial U.S. Approval: 1989 | A-S Medication Solutions | 20240310 | 15 |
| These highlights do not include all the information needed to use Tri-VyLibra safely and effectively. See full prescribing information for Tri-VyLibra. Tri-VyLibra ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Afaxys Pharma, LLC | Aurobindo Pharma Limited | 20240202 | 10 |
| Norgestimate and Ethinyl Estradiol Tablets, USP These highlights do not include all the information needed to use Norgestimate and Ethinyl Estradiol Tablets, USP safely and effectively. See full prescribing information for Norgestimate and Ethinyl Estradiol Tablets, USP. Initial U.S. Approval: 1989 | AvKARE | 20240110 | 3 |
| Norgestimate and Ethinyl Estradiol Tablets, USP These highlights do not include all the information needed to use Norgestimate and Ethinyl Estradiol Tablets, USP safely and effectively. See full prescribing information for Norgestimate and Ethinyl Estradiol Tablets, USP. Initial U.S. Approval: 1989 | AvKARE | 20240110 | 3 |
| Norgestimate and Ethinyl Estradiol Tablets, USP These highlights do not include all the information needed to use Norgestimate and Ethinyl Estradiol Tablets, USP safely and effectively. See full prescribing information for Norgestimate and Ethinyl Estradiol Tablets, USP. Initial U.S. Approval: 1989 | AvKARE | 20240110 | 3 |
| These highlights do not include all the information needed to use TRI-MILI safely and effectively. See full prescribing information for TRI-MILI. Tri-Mili ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Aurobindo Pharma Limited | 20240102 | 13 |
| These highlights do not include all the information needed to use Tri-Lo-Estarylla safely and effectively. See full prescribing information for Tri-Lo-Estarylla. Tri-Lo-Estarylla ® (norgestimate and ethinyl estradiol tablets) for oral use Initial U.S. Approval: 1989 | Xiromed, LLC. | XIROMED PHARMA ESPANA, S.L. | 20231221 | 7 |
| These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989 | Preferred Pharmaceuticals Inc | 20231004 | 3 |
| These highlights do not include all the information needed to use Tri-Estarylla safely and effectively. See full prescribing information for Tri-Estarylla. Tri-Estarylla ® (norgestimate and ethinyl estradiol, USP) tablets, for oral use Initial U.S. Approval: 1989 | Xiromed, LLC. | XIROMED PHARMA ESPANA, S.L. | Laboratorios Leon Farma SA | Industriale Chimica S.r.L | Aspen Oss B.V. | 20230801 | 9 |
| These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989 | RPK Pharmaceuticals, Inc. | 20230607 | 5 |
| These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989 | RPK Pharmaceuticals, Inc. | 20230607 | 3 |
| These highlights do not include all the information needed to use TRI-VYLIBRA ® LO safely and effectively. See full prescribing information for TRI-VYLIBRA ® LO. Tri-VyLibra ® Lo (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989 | RPK Pharmaceuticals, Inc. | 20230607 | 4 |
| These highlights do not include all the information needed to use Tri-VyLibra safely and effectively. See full prescribing information for Tri-VyLibra. Tri-VyLibra ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | RPK Pharmaceuticals, Inc. | 20230607 | 3 |
| These highlights do not include all the information needed to use VyLibra safely and effectively. See full prescribing information for VyLibra. VyLibra ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | RPK Pharmaceuticals, Inc. | 20230607 | 3 |
| These highlights do not include all the information needed to use TRI-VYLIBRA ® LO safely and effectively. See full prescribing information for TRI-VYLIBRA ® LO. Tri-VyLibra ® Lo (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989 | Afaxys Pharma, LLC | Aurobindo Pharma Limited | 20230504 | 6 |
| These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989 | A-S Medication Solutions | 20230328 | 8 |
| These highlights do not include all the information needed to use Estarylla safely and effectively. See full prescribing information for Estarylla. Estarylla ® (NORGESTIMATE and ETHINYL ESTRADIOL tablets) for oral use Initial U.S. Approval: 1989 | Xiromed, LLC. | XIROMED PHARMA ESPANA, S.L. | 20230201 | 7 |
| These highlights do not include all the information needed to use TRI-LO-SPRINTEC safely and effectively. See full prescribing information for TRI-LO-SPRINTEC. TRI-LO-SPRINTEC ® (norgestimate/ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989 | Proficient Rx LP | 20230201 | 4 |
| These highlights do not include all the information needed to use TRI-LO-MILI® safely and effectively. See full prescribing information for TRI-LO-MILI. TRI-LO-MILI (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989 | Proficient Rx LP | 20230101 | 1 |
| These highlights do not include all the information needed to use Nymyo safely and effectively. See full prescribing information for Nymyo. Nymyo (norgestimate/ethinyl estradiol tablets) for oral use. Initial U.S. Approval:1989 | Mayne Pharma Inc. | Novast Laboratories, Ltd. | 20221208 | 2 |
| These highlights do not include all the information needed to use Tri-Nymyo safely and effectively. See full prescribing information forTri-Nymyo. Tri-Nymyo (norgestimate/ethinyl estradiol tablets) for oral use. Initial U.S. Approval: 1989 | Mayne Pharma Inc. | Novast Laboratories, Ltd. | 20221208 | 2 |
| These highlights do not include all the information needed to use TRI-LO-MILI® safely and effectively. See full prescribing information for TRI-LO-MILI. TRI-LO-MILI (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989 | Aurobindo Pharma Limited | 20220908 | 10 |
| These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989 | Proficient Rx LP | 20220401 | 4 |
| These highlights do not include all the information needed to use SPRINTEC safely and effectively. See full prescribing information for SPRINTEC. SPRINTEC ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Proficient Rx LP | 20220401 | 5 |
| These highlights do not include all the information needed to use TRI-LO-SPRINTEC safely and effectively. See full prescribing information for TRI-LO-SPRINTEC. TRI-LO-SPRINTEC ® (norgestimate/ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989 | Teva Pharmaceuticals USA, Inc. | 20211231 | 9 |
| These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, for oral use Initial U.S. Approval: 1989 | A-S Medication Solutions | 20200118 | 3 |
| These highlights do not include all the information needed to use TRI FEMYNOR safely and effectively. See full prescribing information for TRI FEMYNOR. TRI FEMYNOR™ (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | A-S Medication Solutions | 20200118 | 2 |
| Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets USP) | Proficient Rx LP | 20200101 | 3 |
| These highlights do not include all the information needed to use TRI-LO-MARZIA safely and effectively. See full prescribing information for TRI-LO-MARZIA TRI-LO-MARZIA™ (norgestimate and ethinyl estradiol tablets USP), for oral use Initial U.S. Approval: 1989 | Proficient Rx LP | 20191101 | 3 |
| These highlights do not include all the information needed to use MonoNessa or TriNessa safely and effectively. See full prescribing information for MonoNessa and TriNessa. MonoNessa ® and TriNessa ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Preferred Pharmaceuticals Inc, | 20190412 | 2 |
| These highlights do not include all the information needed to use MonoNessa or TriNessa safely and effectively. See full prescribing information for MonoNessa and TriNessa. MonoNessa ® and TriNessa ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Central Texas Community Health Centers | 20190109 | 2 |
| These highlights do not include all the information needed to use MILI safely and effectively. See full prescribing information for MILI. MILI TM (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | A-S Medication Solutions | 20190102 | 1 |
| These highlights do not include all the information needed to use PREVIFEM ® or TRI-PREVIFEM ® safely and effectively. See full prescribing information for PREVIFEM ® and TRI-PREVIFEM ® . PREVIFEM ® and TRI-PREVIFEM ® (norgestimate/ethinyl estradiol tablets), for oral use Initial U.S. Approval: 1989 | Central Texas Community Health Centers | 20161202 | 2 |
| These highlights do not include all the information needed to use TRI FEMYNOR safely and effectively. See full prescribing information for TRI FEMYNOR. TRI FEMYNOR™ (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Amneal Pharmaceuticals NY LLC | 20160830 | 6 |
| These highlights do not include all the information needed to use FEMYNOR safely and effectively. See full prescribing information for FEMYNOR. FEMYNOR™ (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Amneal Pharmaceuticals NY LLC | Haupt Pharma Muenster GmbH | 20160530 | 9 |
| These highlights do not include all the information needed to use Tri-Sprintec safely and effectively. See full prescribing information for Tri-Sprintec. TRI-SPRINTEC ® (norgestimate/ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 | Central Texas Community Health Centers | 20160129 | 1 |
| TriNessa ® Tablets (norgestimate and ethinyl estradiol) | Physicians Total Care, Inc. | 20120523 | 1 |
| Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets - triphasic regimen) PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. Rx only | Physicians Total Care, Inc. | 20120419 | 1 |
| Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg | Glenmark Generics Inc., USA | Glenmark Generics Limited | 20120413 | 5 |
| ORTHO TRI-CYCLEN ® TABLETS ORTHO-CYCLEN ® TABLETS (norgestimate/ethinyl estradiol) | Physicians Total Care, Inc. | 20120227 | 2 |
| TriNessa ® Tablets (norgestimate and ethinyl estradiol) | Rebel Distributors Corp | 20110913 | 1 |
| Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets - triphasic regimen) PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. Rx only | Rebel Distributors Corp | 20110906 | 1 |
| Tri-Sprintec ® (norgestimate and ethinyl estradiol tablets - triphasic regimen) PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. Rx only | MedVantx, Inc. | Blenheim Pharmacal, Inc. | 20110803 | 1 |
| ORTHO TRI-CYCLEN ® Lo Tablets (norgestimate/ethinyl estradiol) | Physicians Total Care, Inc. | Ortho Pharmaceutical Division of Janssen Ortho, LLC | Janssen Ortho LLC | Ortho Biologics LLC a division of OMJ Pharmaceutical, Inc. | Sanofi Chimie | Gedeon Richter Plc | NV Organon | Ortho-McNeil-Janssen Pharmaceuticals, Inc, Ortho-McNeil Unit | Ortho-McNeil-Janssen Pharmaceuticals, Inc. | 20110203 | 4 |
| Sprintec ® (norgestimate and ethinyl estradiol tablets) Rx only | Rebel Distributors Corp | 20110117 | 1 |