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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE

ANDA

Tentative Approval

EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | A213654 | LUPIN LTD

Products (4)

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#001 — 5MG; 1GM

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TABLET, EXTENDED RELEASE;ORAL | TA Date: 2021-01-06 00:00:00

No patent or exclusivity listings for this strength.

#002 — 10MG; 1GM

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TABLET, EXTENDED RELEASE;ORAL | TA Date: 2021-01-06 00:00:00

#003 — 12.5MG; 1GM

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TABLET, EXTENDED RELEASE;ORAL | TA Date: 2021-01-06 00:00:00

#004 — 25MG; 1GM

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TABLET, EXTENDED RELEASE;ORAL | TA Date: 2021-01-06 00:00:00