FDA Orange Book
Generic for Minastrin 24 Fe
Minastrin 24 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 Minastrin 24 Fe is norethindrone acetate and ethinyl estradiol. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Minastrin 24 Fe products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.02MG;1MG | Discontinued | None | 9 | AB |
NDA 203667, 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 LLC (AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC) | 090938 | AB (A-rated, therapeutically equivalent) | December 1, 2014 | 0.02MG;1MG |
| NOVAST LABORATORIES LTD | 202994 | AB (A-rated, therapeutically equivalent) | February 18, 2015 | 0.02MG;1MG |
| LUPIN LTD | 091398 | AB (A-rated, therapeutically equivalent) | October 28, 2015 | 0.02MG;1MG |
| LUPIN INC | 206287 | AB (A-rated, therapeutically equivalent) | May 24, 2016 | 0.02MG;1MG |
| AUROBINDO PHARMA LTD | 207504 | AB (A-rated, therapeutically equivalent) | June 15, 2017 | 0.02MG;1MG |
| GLENMARK PHARMACEUTICALS LTD | 204847 | AB (A-rated, therapeutically equivalent) | November 17, 2017 | 0.02MG;1MG |
| GLENMARK PHARMACEUTICALS LTD | 210369 | AB (A-rated, therapeutically equivalent) | December 26, 2017 | 0.02MG;1MG |
| XIROMED PHARMA ESPANA SL | 209609 | AB (A-rated, therapeutically equivalent) | July 16, 2018 | 0.02MG;1MG |
| TEVA PHARMACEUTICALS USA INC | 210087 | AB (A-rated, therapeutically equivalent) | April 7, 2020 | 0.02MG;1MG |
Questions
Is there a generic for Minastrin 24 Fe?
Yes. The generic name for Minastrin 24 Fe is norethindrone acetate and ethinyl estradiol. 8 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 Minastrin 24 Fe?
The active ingredient in Minastrin 24 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.