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FDA ANDA · ANDA208449
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
Sponsor: ZYDUS PHARMS
APPLICATION
ANDA208449
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-30
LATEST ACTION
2026-03-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LINAGLIPTIN AND METFORMIN HYDROCHLORIDEPrescription
LINAGLIPTIN 2.5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
LINAGLIPTIN AND METFORMIN HYDROCHLORIDEPrescription
LINAGLIPTIN 2.5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
LINAGLIPTIN AND METFORMIN HYDROCHLORIDEPrescription
LINAGLIPTIN 2.5MG, METFORMIN HYDROCHLORIDE 850MG · TABLET · ORAL
Approval history
2026-03-11Labeling · Supplement 1 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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