FDA Orange Book
Generic for Lo/ovral-28
Lo/ovral-28 contains ethinyl estradiol and norgestrel. 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 Lo/ovral-28 is ethinyl estradiol and norgestrel. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lo/ovral-28 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-28 | 0.03MG;0.3MG | Discontinued | None | 4 | AB |
NDA 017802, held by WYETH PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ethinyl estradiol and norgestrel
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES SA | 075288 | AB (A-rated, therapeutically equivalent) | July 28, 1999 | 0.03MG;0.3MG |
| DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC | 075840 | AB (A-rated, therapeutically equivalent) | November 30, 2001 | 0.03MG;0.3MG |
| NOVAST LABORATORIES LTD | 091105 | AB (A-rated, therapeutically equivalent) | March 28, 2012 | 0.03MG;0.3MG |
| LUPIN LTD | 202980 | AB (A-rated, therapeutically equivalent) | July 31, 2023 | 0.03MG;0.3MG |
Questions
Is there a generic for Lo/ovral-28?
Yes. The generic name for Lo/ovral-28 is ethinyl estradiol and norgestrel. 4 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 Lo/ovral-28?
The active ingredient in Lo/ovral-28 is ethinyl estradiol and norgestrel, 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.