FDA Orange Book
Generic for Loniten
Loniten contains minoxidil. 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 Loniten is minoxidil. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Loniten products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 3 | AB |
| tablet, oral | 2.5MG | Discontinued | None | 3 | AB |
NDA 018154, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic minoxidil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 071345 | AB (A-rated, therapeutically equivalent) | March 3, 1987 | 10MG |
| WATSON LABORATORIES INC | 071344 | AB (A-rated, therapeutically equivalent) | March 3, 1987 | 2.5MG |
| PH HEALTH LTD | 071839 | AB (A-rated, therapeutically equivalent) | November 14, 1988 | 10MG |
| PH HEALTH LTD | 071826 | AB (A-rated, therapeutically equivalent) | November 14, 1988 | 2.5MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 072709 | AB (A-rated, therapeutically equivalent) | December 14, 1995 | 10MG, 2.5MG |
Questions
Is there a generic for Loniten?
Yes. The generic name for Loniten is minoxidil. 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 Loniten?
The active ingredient in Loniten is minoxidil, 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.