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Medicines · US (FDA)

FDA 2015

FDA

Norethindrone and Ethinyl Estradiol

Approved 21 Oct 2015OralTablet

The FDA lists this product in 13 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: ETHINYL ESTRADIOL 0.035MG; NORETHINDRONE 0.5MG

Strengths and forms

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

ETHINYL ESTRADIOL 0.035MG; NORETHINDRONE 0.4MG · TabletANDA200897-001 · Discontinued
ETHINYL ESTRADIOL 0.035MG; NORETHINDRONE 0.4MG · TabletANDA078323-001 · Prescription
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG; NORETHINDRONE 0.5MG,0.75MG,1MG · TabletANDA200486-001 · Discontinued
ETHINYL ESTRADIOL 0.05MG; NORETHINDRONE 1MG · TabletANDA203006-001 · Discontinued
ETHINYL ESTRADIOL 0.035MG; NORETHINDRONE 1MG · TabletANDA070685-001 · Discontinued
ETHINYL ESTRADIOL 0.035MG; NORETHINDRONE 1MG · TabletANDA070687-001 · Prescription
ETHINYL ESTRADIOL 0.035MG; NORETHINDRONE 0.5MG · TabletThis page
ETHINYL ESTRADIOL 0.035MG; NORETHINDRONE 0.5MG · TabletANDA070686-001 · Discontinued

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG; NORETHINDRONE 0.5MG,0.75MG,1MG · TabletANDA076393-001 · Discontinued

ETHINYL ESTRADIOL 0.035MG; NORETHINDRONE 0.4MG · TabletANDA078379-001 · Discontinued

ETHINYL ESTRADIOL 0.035MG; NORETHINDRONE 0.5MG · TabletANDA070684-001 · Discontinued

ETHINYL ESTRADIOL 0.035MG; NORETHINDRONE 1MG · TabletANDA200489-001 · Discontinued

ETHINYL ESTRADIOL 0.035MG; NORETHINDRONE 1MG · TabletANDA206864-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA200488.

Open Drugs@FDA

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Norethindrone and Ethinyl Estradiol
Active substance: ethinyl estradiol
Route: Oral
Dosage form: Tablet
Applicant: Mylan Labs LTD
Status: Discontinued
FDA approval: 21 Oct 2015
Application: ANDA200488-001