FDA.reportPublic FDA data

NORELGESTROMIN Pharmacologic Class Indexing

Class set ID
95abdf46-1301-429f-ad11-79c431663ef5
Version
2
Effective date
20180813
Type
Indexing - Pharmacologic Class

Mapped DailyMed Labels#

Label, Manufacturer, Effective table
LabelManufacturerEffectiveSPL version
NORELGESTROMIN AND ETHINYL ESTRADIOL transdermal systemZydus Lifesciences Limited202604162
These highlights do not include all the information needed to use NORELGESTROMIN AND ETHINYL ESTRADIOL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for NORELGESTROMIN AND ETHINYL ESTRADIOL TRANSDERMAL SYSTEM NORELGESTROMIN AND ETHINYL ESTRADIOL transdermal system Initial U.S. Approval: 2001Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited202604163
ZAFEMY ® (norelgestromin and ethinyl estradiol transdermal system) These highlights do not include all the information needed to use ZAFEMY safely and effectively. See full prescribing information for ZAFEMY . ZAFEMY ® (norelgestromin and ethinyl estradiol transdermal system) Initial U.S. Approval: 2001AvKARE202601192
These highlights do not include all the information needed to use XULANE ® safely and effectively. See full prescribing information for XULANE. XULANE ® (norelgestromin and ethinyl estradiol transdermal system) Initial U.S. Approval: 2001A-S Medication Solutions2024022715
These highlights do not include all the information needed to use ZAFEMY safely and effectively. See full prescribing information for ZAFEMY . ZAFEMY ® (norelgestromin and ethinyl estradiol transdermal system) Initial U.S. Approval: 2001Bryant Ranch Prepack20240105100
These highlights do not include all the information needed to use ZAFEMY safely and effectively. See full prescribing information for ZAFEMY . ZAFEMY ® (norelgestromin and ethinyl estradiol transdermal system) Initial U.S. Approval: 2001Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLC202204307
These highlights do not include all the information needed to use NORELGESTROMIN AND ETHINYL ESTRADIOL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for NORELGESTROMIN AND ETHINYL ESTRADIOL TRANSDERMAL SYSTEM . NORELGESTROMIN AND ETHINYL ESTRADIOL transdermal system Initial U.S. Approval: 2001Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLC202203309
These highlights do not include all the information needed to use XULANE ® safely and effectively. See full prescribing information for XULANE. XULANE ® (norelgestromin and ethinyl estradiol transdermal system) Initial U.S. Approval: 2001Mylan Pharmaceuticals Inc.2022030416