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DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE) | LOERadar

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DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

ANDA

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | A211583 | TEVA PHARMACEUTICALS USA INC

5 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: XIGDUO XR(TE code: AB)

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 9, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

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#001 — 2.5MG;1GM

AB

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 6, 2026

No patent or exclusivity listings for this strength.

#002 — 5MG;500MG

AB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 6, 2026

#003 — 5MG;1GM

AB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 6, 2026

#004 — 10MG;500MG

AB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 6, 2026

#005 — 10MG;1GM

AB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 6, 2026