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Last Updated: March 28, 2024

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. 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 021040
Tradename:PREFEST
Applicant:Teva Womens
Ingredient:estradiol; norgestimate
Patents:0

Profile 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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 22, 1999TE:RLD:Yes

Expired US Patents for NDA 021040

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999 ⤷  Try a Trial ⤷  Try a Trial
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999 ⤷  Try a Trial ⤷  Try a Trial
Teva Womens PREFEST estradiol; norgestimate TABLET;ORAL 021040-001 Oct 22, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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