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ACTIVE SUBSTANCE / INN

NORETHINDRONE

Brand name(s): ORTHO-NOVUM 10-21, NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, NORETHINDRONE AND ETHINYL ESTRADIOL, HEATHER, ORTHO-NOVUM 1/50 21, ORTHO-NOVUM 7/14-21, ORTHO-NOVUM 2-21, WERA, ORTHO-NOVUM 7/14-28, NORETHINDRONE
FDA LISTED
PRESCRIPTION
DISCONTINUED
NDA019004
ANDA202260
ACTIVE SUBSTANCE
Norethindrone
REGULATORS
FDA
SPONSORS / MAH
WATSON LABS, AMNEAL PHARMS, ORTHO MCNEIL PHARM
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
NORETHINDRONE AND ETHINYL ESTRADIOLANDA078323WATSON LABSPrescription
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEANDA078892AMNEAL PHARMSPrescription
HEATHERANDA090454GLENMARK PHARMS LTDPrescription
WERAANDA091204NOVAST LABS LTDPrescription
ORTHO-NOVUM 7/14-21NDA019004ORTHO MCNEIL PHARMDiscontinued
ORTHO-NOVUM 7/14-28NDA019004ORTHO MCNEIL PHARMDiscontinued
NORETHINDRONEANDA202260AMNEAL PHARMSDiscontinued
ORTHO-NOVUM 1/50 21NDA012728ORTHO MCNEIL PHARMDiscontinued
ORTHO-NOVUM 2-21NDA012728ORTHO MCNEIL PHARMDiscontinued
ORTHO-NOVUM 10-21NDA012728ORTHO MCNEIL PHARMDiscontinued

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