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ACTIVE SUBSTANCE / INN

MESTRANOL

Brand name(s): ORTHO-NOVUM 10-21, ENOVID-E, ORTHO-NOVUM 1/50 28, NORETHIN 1/50M-21, ENOVID, ORTHO-NOVUM 2-21, ENOVID-E 21, ORTHO-NOVUM 1/80 28, ORTHO-NOVUM 1/80 21, ORTHO-NOVUM 1/50 21
FDA LISTED
DISCONTINUED
ANDA071539
NDA010976
ACTIVE SUBSTANCE
Mestranol
REGULATORS
FDA
SPONSORS / MAH
HERITAGE PHARMA, GD SEARLE LLC, ORTHO MCNEIL PHARM
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ORTHO-NOVUM 1/50 21NDA012728ORTHO MCNEIL PHARMDiscontinued
ORTHO-NOVUM 2-21NDA012728ORTHO MCNEIL PHARMDiscontinued
ORTHO-NOVUM 10-21NDA012728ORTHO MCNEIL PHARMDiscontinued
ENOVIDNDA010976GD SEARLE LLCDiscontinued
ENOVID-ENDA010976GD SEARLE LLCDiscontinued
ENOVID-E 21NDA010976GD SEARLE LLCDiscontinued
ORTHO-NOVUM 1/50 28NDA016709ORTHO MCNEIL JANSSENDiscontinued
NORETHIN 1/50M-21ANDA071539HERITAGE PHARMADiscontinued
ORTHO-NOVUM 1/80 28NDA016715ORTHO MCNEIL PHARMDiscontinued
ORTHO-NOVUM 1/80 21NDA016715ORTHO MCNEIL PHARMDiscontinued

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