Tilia Fe
(Norethindrone Acetate and Ethinyl Estradiol Tablets USP and Ferrous Fumarate Tablets*)*Ferrous fumarate tablets are not USP for dissolution and assay.
Approved
Approval ID
01765e76-e656-4539-8112-8b7709597c79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2010
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 and Ethinyl Estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6274
Application NumberANDA076629
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone Acetate and Ethinyl Estradiol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2011
FDA Product Classification