femhrt
femhrt(norethindrone acetate/ethinyl estradiol tablets)
Approved
Approval ID
434511bb-ebf9-4e25-9ef8-90e4c6786361
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 2, 2008
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
norethindrone acetate/ethinyl estradiol
PRODUCT DETAILS
NDC Product Code54868-4679
Application NumberNDA021065
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 31, 2010
Generic Namenorethindrone acetate/ethinyl estradiol
INGREDIENTS (6)
NORETHINDRONE ACETATEActive
Quantity: 1 mg in 1 1
Code: 9S44LIC7OJ
Classification: ACTIB
ETHINYL ESTRADIOLActive
Quantity: 5 ug in 1 1
Code: 423D2T571U
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT