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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.

ALOGLIPTIN; METFORMIN HYDROCHLORIDE

ANDA

Tentative Approval

ALOGLIPTIN; METFORMIN HYDROCHLORIDE | A210160 | TORRENT PHARMS LTD

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 18, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 12.5MG BASE;500MG

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TABLET;ORAL | TA Date: 2018-12-19 00:00:00

No patent or exclusivity listings for this strength.

#002 — EQ 12.5MG BASE;1GM

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TABLET;ORAL | TA Date: 2018-12-19 00:00:00