FDA.reportPublic FDA data

Application 209627

Type
NDA
Sponsor
THERAPEUTICSMD INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANNOVERAETHINYL ESTRADIOL; SEGESTERONE ACETATERING;VAGINAL0.013MG/24HR;0.15MG/24HRYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12822-0313ANNOVERASEGESTERONE ACETATE, ETHINYL ESTRADIOLQPharma ABNDACurrent
50261-313ANNOVERAsegesterone acetate and ethinyl estradiolTherapeuticsMD, Inc.NDACurrent
50261-313ANNOVERAsegesterone acetate and ethinyl estradiolTherapeuticsMD, Inc.NDACurrent
50261-313ANNOVERAsegesterone acetate and ethinyl estradiolTherapeuticsMD, Inc.NDACurrent
50261-313ANNOVERAsegesterone acetate and ethinyl estradiolTherapeuticsMD, Inc.NDACurrent
50261-313ANNOVERAsegesterone acetate and ethinyl estradiolTherapeuticsMD, Inc.NDACurrent
50261-313ANNOVERAsegesterone acetate and ethinyl estradiolTherapeuticsMD, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70973SUPPL2022-05-04
55419ORIG2018-09-10
55199ORIG2018-08-17
55163ORIG2018-08-10