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ACTIVE SUBSTANCE / INN

NORGESTIMATE

Brand name(s): ORTHO CYCLEN-28, ESTARYLLA, TRI-LO-LINYAH, NORGESTIMATE AND ETHINYL ESTRADIOL, ORTHO CYCLEN-21, TRI-LO-MILI, NORGESTIMATE; ETHINYL ESTRADIOL, TRI-PREVIFEM
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
ANDA090794
ANDA200494
ACTIVE SUBSTANCE
Norgestimate
REGULATORS
FDA
SPONSORS / MAH
AUROBINDO PHARMA, PH HEALTH, NOVAST LABS
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TRI-PREVIFEMANDA076335PH HEALTHDiscontinued
NORGESTIMATE; ETHINYL ESTRADIOLANDA200494GLENMARK PHARMS LTDPrescription
NORGESTIMATE AND ETHINYL ESTRADIOLANDA200494GLENMARK PHARMS LTDPrescription
NORGESTIMATE AND ETHINYL ESTRADIOLANDA201897XIROMEDDiscontinued
ORTHO CYCLEN-28NDA019653JANSSEN PHARMSDiscontinued
ORTHO CYCLEN-21NDA019653JANSSEN PHARMSDiscontinued
TRI-LO-LINYAHANDA090541NOVAST LABSNone (Tentative Approval)
TRI-LO-LINYAHANDA090541NOVAST LABSPrescription
TRI-LO-MILIANDA205762AUROBINDO PHARMAPrescription
ESTARYLLAANDA090794XIROMEDPrescription

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