Progestogens and estrogens, fixed combinations

Norethindrone and Ethinyl Estradiol (7/14)

Approved 24 Sept 1991OralTablet

The FDA lists this product in 2 strengths and forms.

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Composition

Active ingredients: ETHINYL ESTRADIOL 0.035MG,0.035MG; NORETHINDRONE 0.5MG,1MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

ETHINYL ESTRADIOL 0.035MG,0.035MG; NORETHINDRONE 0.5MG,1MG · TabletANDA071041-001 · Discontinued
ETHINYL ESTRADIOL 0.035MG,0.035MG; NORETHINDRONE 0.5MG,1MG · TabletThis page

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA071042.

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At a glance

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Brand name: Norethindrone and Ethinyl Estradiol (7/14)
Active substance: ethinyl estradiol
Drug class: Progestogens and estrogens, fixed combinations, Progestogens and estrogens, sequential preparations
Group: Sex hormones and modulators
Route: Oral
Dosage form: Tablet
Applicant: Watson Labs
Status: Discontinued
FDA approval: 24 Sept 1991
Application: ANDA071042-001
RxCUI: 4124