FDA Orange Book

Generic for Panwarfin

Panwarfin contains warfarin. 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 Panwarfin is warfarin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Panwarfin products in the Orange Book

Panwarfin products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral10MGDiscontinuedNone6AB
tablet, oral2.5MGDiscontinuedNone6AB
tablet, oral2MGDiscontinuedNone6AB
tablet, oral5MGDiscontinuedNone6AB
tablet, oral7.5MGDiscontinuedNone6AB

NDA 017020, held by ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic warfarin

Approved generic versions of Panwarfin
CompanyANDATE codeApprovedStrengths
TARO PHARMACEUTICAL INDUSTRIES LTD040301AB (A-rated, therapeutically equivalent)July 15, 199910MG, 2.5MG, 2MG, 5MG, 7.5MG
UPSHER SMITH LABORATORIES LLC040416AB (A-rated, therapeutically equivalent)October 2, 200310MG, 2.5MG, 2MG, 5MG, 7.5MG
ZYDUS PHARMACEUTICALS USA INC040663AB (A-rated, therapeutically equivalent)May 30, 200610MG, 2.5MG, 2MG, 5MG, 7.5MG
PLIVA INC040616AB (A-rated, therapeutically equivalent)July 5, 200610MG, 2.5MG, 2MG, 5MG, 7.5MG
INVAGEN PHARMACEUTICALS INC090935AB (A-rated, therapeutically equivalent)May 25, 201110MG, 2.5MG, 2MG, 5MG, 7.5MG
AMNEAL PHARMACEUTICALS202202AB (A-rated, therapeutically equivalent)March 4, 201310MG, 2.5MG, 2MG, 5MG, 7.5MG

Questions

Is there a generic for Panwarfin?

Yes. The generic name for Panwarfin is warfarin. 6 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 Panwarfin?

The active ingredient in Panwarfin is warfarin, 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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