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Profile for Tradename: ESTRACE

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Estrace is a drug marketed by Warner Chilcott Us and Bristol Myers Squibb and is included in four NDAs.

The generic ingredient in ESTRACE is estradiol. There are seventy-four drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the estradiol profile page.

Summary for Tradename: ESTRACE

Patents:0
Applicants:2
NDAs:4

Clinical Trials for: ESTRACE

Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
Status: Active, not recruiting Condition: Atrophic Vaginitis; Breast Cancer

Postpartum Depression: Transdermal Estradiol Versus Sertraline
Status: Terminated Condition: Postpartum Depression

A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
Status: Completed Condition: Atrophic Vaginitis

Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
Status: Completed Condition: Hot Flashes

Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients
Status: Completed Condition: Sexual Dysfunction, Physiological

Duragen Versus Duraguard in Chiari Surgery
Status: Completed Condition: Chiari Malformation

ELITE: Early Versus Late Intervention Trial With Estradiol
Status: Active, not recruiting Condition: Atherosclerosis

Perimenopausal Effects of Estradiol on Reward Responsiveness
Status: Not yet recruiting Condition: Perimenopausal Depression

A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC
Status: Completed Condition: Contraception; Bleeding

MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms
Status: Completed Condition: Hot Flashes; Menopause; Vasomotor Disturbance

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott Us
ESTRACE
estradiol
CREAM;VAGINAL086069-001Jan 31, 1984RXYes<disabled><disabled>
Bristol Myers Squibb
ESTRACE
estradiol
TABLET;ORAL084500-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Bristol Myers Squibb
ESTRACE
estradiol
TABLET;ORAL081295-001Jun 30, 1993DISCNNo<disabled><disabled>
Bristol Myers Squibb
ESTRACE
estradiol
TABLET;ORAL084499-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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