Dipeptidyl peptidase 4 (DPP-4) inhibitors

Sitagliptin and Metformin HCL

Approved 11 Dec 2024Tablet

The FDA lists this product in 5 strengths and forms.

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Composition

Active ingredients: SITAGLIPTIN, METFORMIN HYDROCHLORIDE 1000MG ER TABLET

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

SITAGLIPTIN, METFORMIN HYDROCHLORIDE 1000MG · TabletANDA218971-005 · Tentative approval
SITAGLIPTIN, METFORMIN HYDROCHLORIDE 500MG · TabletANDA218971-003 · Tentative approval
SITAGLIPTIN, METFORMIN HYDROCHLORIDE 1000MG ER TABLET · TabletThis page
SITAGLIPTIN, METFORMIN HYDROCHLORIDE 50MG · TabletANDA218971-004 · Tentative approval
SITAGLIPTIN, METFORMIN HYDROCHLORIDE EQ 100MG BASE TABLET · TabletANDA218971-002 · Tentative approval

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA218971.

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At a glance

Brand name: Sitagliptin and Metformin HCL
Active substance: sitagliptin, metformin hydrochloride
Drug class: Dipeptidyl peptidase 4 (DPP-4) inhibitors, Biguanides, Combinations of oral blood glucose lowering drugs
Group: Diabetes medicines
Dosage form: Tablet
Applicant: Mankind Pharma LTD
Status: Tentative approval
FDA approval: 11 Dec 2024
Application: ANDA218971-001
RxCUI: 729717