FDA Orange Book
Generic for Mavik
Mavik contains trandolapril. 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 Mavik is trandolapril. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Mavik products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1MG | Discontinued | None | 3 | AB |
| tablet, oral | 2MG | Discontinued | None | 3 | AB |
| tablet, oral | 4MG | Discontinued | None | 3 | AB |
NDA 020528, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic trandolapril
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 078438 | AB (A-rated, therapeutically equivalent) | June 12, 2007 | 1MG, 2MG, 4MG |
| LUPIN LTD | 077522 | AB (A-rated, therapeutically equivalent) | June 12, 2007 | 1MG, 2MG, 4MG |
| EPIC PHARMA LLC | 078508 | AB (A-rated, therapeutically equivalent) | June 18, 2008 | 1MG, 2MG, 4MG |
Questions
Is there a generic for Mavik?
Yes. The generic name for Mavik is trandolapril. 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 Mavik?
The active ingredient in Mavik is trandolapril, 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.