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Medicines · US (FDA)
Sex hormones and modulators

FDA 1999

Natural and semisynthetic estrogens, plain

Estradiol

Approved 21 Apr 1999OralTablet

The FDA lists this product in 60 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: ESTRADIOL 1MG

Strengths and forms

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

ESTRADIOL 0.075MG/24HR · Film, extended releaseANDA202985-005 · Prescription
ESTRADIOL 0.05MG/24HR · Film, extended releaseANDA202985-003 · Prescription
ESTRADIOL 0.025MG/24HR · Film, extended releaseANDA202985-001 · Prescription
ESTRADIOL 0.1MG/24HR · Film, extended releaseANDA202985-006 · Prescription
ESTRADIOL 0.06MG/24HR · Film, extended releaseANDA202985-004 · Prescription
ESTRADIOL 0.0375MG/24HR · Film, extended releaseANDA202985-002 · Prescription
ESTRADIOL 0.01% · CreamANDA210488-001 · Prescription
ESTRADIOL 1MG · TabletANDA217334-002 · Prescription
ESTRADIOL 2MG · TabletANDA217334-003 · Prescription
ESTRADIOL 0.5MG · TabletANDA217334-001 · Prescription
ESTRADIOL 2MG · TabletANDA040197-003 · Prescription
ESTRADIOL 0.5MG · Tablet

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ANDA040197-001 · Prescription

ESTRADIOL 1MG · TabletANDA040197-002 · Prescription

ESTRADIOL 1MG · TabletThis page

ESTRADIOL 2MG · TabletANDA040326-003 · Discontinued

ESTRADIOL 0.5MG · TabletANDA040326-001 · Discontinued

ESTRADIOL 0.075MG/24HR · SystemANDA201675-004 · Prescription

ESTRADIOL 0.0375MG/24HR · SystemANDA201675-002 · Prescription

ESTRADIOL 0.1MG/24HR · SystemANDA201675-005 · Prescription

ESTRADIOL 0.05MG/24HR · SystemANDA201675-003 · Prescription

ESTRADIOL 0.025MG/24HR · SystemANDA201675-001 · Prescription

ESTRADIOL 0.01% · CreamANDA208788-001 · Prescription

ESTRADIOL 0.1MG/DAY · SystemANDA020167-005 · Prescription

ESTRADIOL 0.05MG/DAY · SystemANDA020167-003 · Prescription

ESTRADIOL 0.025MG/DAY · SystemANDA020167-001 · Prescription

ESTRADIOL 0.075MG/DAY · SystemANDA020167-004 · Prescription

ESTRADIOL 0.0375MG/DAY · SystemANDA020167-002 · Prescription

ESTRADIOL 0.06% (1.25GM/ACTIVATION) · Gel, meteredANDA216160-001 · Prescription

ESTRADIOL 0.06% (1.25GM/ACTIVATION) · Gel, meteredANDA218214-001 · Prescription

ESTRADIOL 0.1% (1.25GM/PACKET) · GelANDA218507-005 · Prescription

ESTRADIOL 0.1% (0.75GM/PACKET) · GelANDA218507-003 · Prescription

ESTRADIOL 0.1% (0.25GM/PACKET) · GelANDA218507-001 · Prescription

ESTRADIOL 0.1% (1GM/PACKET) · GelANDA218507-004 · Prescription

ESTRADIOL 0.1% (0.5GM/PACKET) · GelANDA218507-002 · Prescription

ESTRADIOL 0.05MG/24HR · Film, extended releaseANDA075233-001 · Prescription

ESTRADIOL 0.1% (1GM/PACKET) · GelANDA217610-004 · Prescription

ESTRADIOL 0.1% (0.5GM/PACKET) · GelANDA217610-002 · Prescription

ESTRADIOL 0.1% (1.25GM/PACKET) · GelANDA217610-005 · Prescription

ESTRADIOL 0.1% (0.75GM/PACKET) · GelANDA217610-003 · Prescription

ESTRADIOL 0.1% (0.25GM/PACKET) · GelANDA217610-001 · Prescription

ESTRADIOL 0.014MG/24HR · SystemANDA204379-001 · Prescription

ESTRADIOL 10MCG · TabletANDA205256-001 · Prescription

ESTRADIOL 0.01% · CreamANDA212313-001 · Prescription

ESTRADIOL 0.0375MG/24HR · Film, extended releaseNDA020538-001 · Discontinued

ESTRADIOL 0.1MG/24HR · Film, extended releaseNDA020538-004 · Discontinued

ESTRADIOL 0.075MG/24HR · Film, extended releaseNDA020538-002 · Discontinued

ESTRADIOL 0.05MG/24HR · Film, extended releaseNDA020538-003 · Discontinued

ESTRADIOL 1MG · TabletANDA040297-002 · Discontinued

ESTRADIOL 2MG · TabletANDA040297-003 · Discontinued

ESTRADIOL 0.5MG · TabletANDA040297-001 · Discontinued

ESTRADIOL 0.1MG/24HR · Film, extended releaseANDA206685-005 · Prescription

ESTRADIOL 0.05MG/24HR · Film, extended releaseANDA206685-003 · Prescription

ESTRADIOL 0.025MG/24HR · Film, extended releaseANDA206685-001 · Prescription

ESTRADIOL 0.075MG/24HR · Film, extended releaseANDA206685-004 · Prescription

ESTRADIOL 0.0375MG/24HR · Film, extended releaseANDA206685-002 · Prescription

ESTRADIOL 0.01% · CreamANDA209767-001 · Prescription

ESTRADIOL 0.01% · CreamANDA210194-001 · Prescription

ESTRADIOL 0.075MG/24HR · Film, extended releaseANDA211396-004 · Prescription

ESTRADIOL 0.0375MG/24HR · Film, extended releaseANDA211396-002 · Prescription

ESTRADIOL 0.1MG/24HR · Film, extended releaseANDA211396-005 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA040326.

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: Estradiol
Drug class: Natural and semisynthetic estrogens, plain, Progestogens and estrogens, fixed combinations, Progestogens and estrogens, sequential preparations
Group: Sex hormones and modulators
Route: Oral
Dosage form: Tablet
Applicant: Pharmobedient
Status: Discontinued
FDA approval: 21 Apr 1999
Application: ANDA040326-002
RxCUI: 4083

Guidelines

Guidelines in obstetrics and gynaecology1,051 guidelines in the library

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