FDA Orange Book
Is there a generic for Gwyn Lo?
Gwyn Lo contains norelgestromin 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Gwyn Lo (norelgestromin and ethinyl estradiol). The Orange Book shows its last listed exclusivity ends July 28, 2029.
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Gwyn Lo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| system, transdermal | 0.02MG/24HR;0.22MG/24HR | Marketed (Rx) | None | 0 | None |
NDA 219990, held by VIATRIS SPECIALITY LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Gwyn Lo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | July 28, 2029 | 219990 |
Gwyn Lo NDC codes
Questions
Is there a generic for Gwyn Lo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Gwyn Lo (norelgestromin and ethinyl estradiol). The Orange Book shows its last listed exclusivity ends July 28, 2029.
What is the generic name for Gwyn Lo?
The active ingredient in Gwyn Lo is norelgestromin 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.