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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 020130


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NDA 020130 describes ESTROSTEP FE, which is a drug marketed by Apil and is included in one NDA. Additional details are available on the ESTROSTEP FE profile page.

The generic ingredient in ESTROSTEP FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 020130
Tradename:ESTROSTEP FE
Applicant:Apil
Ingredient:ethinyl estradiol; norethindrone acetate
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 9, 1996TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-28Strength0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 9, 1996TE:RLD:Yes

Expired US Patents for NDA 020130

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ESTROSTEP 21 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 020130-001 Oct 9, 1996 ⤷  Try a Trial ⤷  Try a Trial
Apil ESTROSTEP 21 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 020130-001 Oct 9, 1996 ⤷  Try a Trial ⤷  Try a Trial
Apil ESTROSTEP FE ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 020130-002 Oct 9, 1996 ⤷  Try a Trial ⤷  Try a Trial
Apil ESTROSTEP FE ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 020130-002 Oct 9, 1996 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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