FDA Orange Book

Generic for Symfi

Symfi contains efavirenz, 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

Yes. The generic name for Symfi is efavirenz, lamivudine and tenofovir disoproxil. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Symfi products in the Orange Book

Symfi products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral600MG;300MG;300MGMarketed (Rx)AB1AB

NDA 022142, 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.

Approved generic efavirenz, lamivudine and tenofovir disoproxil

Approved generic versions of Symfi
CompanyANDATE codeApprovedStrengths
LAURUS LABS LTD212786AB (A-rated, therapeutically equivalent)May 14, 2020600MG;300MG;300MG

Symfi NDC codes

Questions

Is there a generic for Symfi?

Yes. The generic name for Symfi is efavirenz, lamivudine and tenofovir disoproxil. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Symfi?

The active ingredient in Symfi is efavirenz, 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.

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