FDA Orange Book
Generic for Estrostep Fe
Estrostep Fe contains norethindrone acetate and ethinyl estradiol. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Estrostep Fe is norethindrone acetate and ethinyl estradiol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Estrostep Fe products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-28 | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG | Discontinued | None | 3 | AB |
NDA 020130, held by ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic norethindrone acetate and ethinyl estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 076105 | AB (A-rated, therapeutically equivalent) | October 26, 2007 | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG |
| XIROMED LLC | 205069 | AB (A-rated, therapeutically equivalent) | June 22, 2018 | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG |
| NOVAST LABORATORIES LTD | 202962 | AB (A-rated, therapeutically equivalent) | April 15, 2020 | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG |
Questions
Is there a generic for Estrostep Fe?
Yes. The generic name for Estrostep Fe is norethindrone acetate and ethinyl estradiol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Estrostep Fe?
The active ingredient in Estrostep Fe is norethindrone acetate and ethinyl estradiol, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.