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Details for New Drug Application (NDA): 021040

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NDA 021040 describes PREFEST, which is a drug marketed by Teva Womens and is included in one NDA. There are two patents protecting this drug. Additional details are available on the PREFEST profile page.

The generic ingredient in PREFEST is estradiol; norgestimate. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol; norgestimate profile page.

Summary for NDA: 021040

Tradename:
PREFEST
Applicant:
Teva Womens
Ingredient:
estradiol; norgestimate
Patents:2
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 22, 1999TE:RLD:No
Patent:6,747,019Patent Expiration:Mar 20, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:HORMONE REPLACEMENT
Patent:7,320,970Patent Expiration:Mar 30, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:PREFEST IS INDICATED IN WOMEN WHO HAVE A UTERUS FOR THE TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE; TREATMENT OF VULVAR AND VAGINAL ATROPHY; PREVENTION OF OSTEOPOROSIS

Expired Orange Book Patents for NDA: 021040

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Womens
PREFEST
estradiol; norgestimate
TABLET;ORAL021040-001Oct 22, 19995,108,995► subscribe
Teva Womens
PREFEST
estradiol; norgestimate
TABLET;ORAL021040-001Oct 22, 19995,382,573► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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