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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.

SAXAGLIPTIN;METFORMIN HYDROCHLORIDE

ANDA

Tentative Approval

SAXAGLIPTIN;METFORMIN HYDROCHLORIDE | A205942 | AMNEAL PHARMS

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 22, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — 5MG;500MG

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TABLET, EXTENDED RELEASE;ORAL | TA Date: 2016-01-21 00:00:00

No patent or exclusivity listings for this strength.

#002 — 2.5MG;1000MG

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TABLET, EXTENDED RELEASE;ORAL | TA Date: 2016-01-21 00:00:00

#003 — 5MG;1000MG

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TABLET, EXTENDED RELEASE;ORAL | TA Date: 2016-01-21 00:00:00