Details for New Drug Application (NDA): 020130
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The generic ingredient in ESTROSTEP FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven 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: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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, 1996 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-28 | Strength | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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, 1996 | TE: | 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 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ESTROSTEP FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 020130-002 | Oct 9, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ESTROSTEP FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-28 | 020130-002 | Oct 9, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ESTROSTEP 21 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 020130-001 | Oct 9, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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