← FDA Drug Approvals (Drugs@FDA)

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: XIROMED · Approved 2018-06-22

Drug application

FDA Application #

ANDA205069

Application type

Abbreviated New Drug Application (Generic)

Brand name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Generic name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Active ingredients

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Dosage form

TABLET

Route

ORAL-28

Marketing status

Prescription

Sponsor

XIROMED

Manufacturer

Mylan Pharmaceuticals Inc.

First approval

2018-06-22

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown