FDA.reportPublic FDA data

Application 084949

Type
ANDA
Sponsor
MONARCH PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MENESTESTROGENS, ESTERIFIEDTABLET;ORAL2.5MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61570-075MENESTesterified estrogensPfizer Laboratories Div Pfizer IncANDACurrent
61570-075MENESTesterified estrogensPfizer Laboratories Div Pfizer IncANDACurrent
61570-075MENESTesterified estrogensPfizer Laboratories Div Pfizer IncANDACurrent
61570-075MENESTesterified estrogensPfizer Laboratories Div Pfizer IncANDACurrent