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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; LINAGLIPTIN

ANDA

Tentative Approval

EMPAGLIFLOZIN;LINAGLIPTIN | A212366 | ALKEM LABS LTD

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 8, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 10MG/5MG

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TABLET;ORAL | TA Date: 2022-08-09 00:00:00

No patent or exclusivity listings for this strength.

#002 — 25MG/5MG

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TABLET;ORAL | TA Date: 2022-08-09 00:00:00