FDA Orange Book

Is there a generic for Cimduo?

Cimduo contains lamivudine and tenofovir disoproxil. 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 Cimduo (lamivudine and tenofovir disoproxil).

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Cimduo products in the Orange Book

Cimduo products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral300MG;300MGMarketed (Rx)None0None

NDA 022141, held by MYLAN LABORATORIES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Cimduo NDC codes

Questions

Is there a generic for Cimduo?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Cimduo (lamivudine and tenofovir disoproxil).

What is the generic name for Cimduo?

The active ingredient in Cimduo is lamivudine and tenofovir disoproxil, 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.

More on Cimduo and Lamivudine and Tenofovir Disoproxil

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