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Medicines · US (FDA)

FDA 2023

FDA

Linagliptin and Metformin Hydrochloride

Approved 30 Mar 2023OralTablet

The FDA lists this product in 14 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: LINAGLIPTIN 2.5MG; METFORMIN HYDROCHLORIDE 500MG

Strengths and forms

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

LINAGLIPTIN 2.5MG; METFORMIN HYDROCHLORIDE 1GM · TabletANDA208427-003 · Prescription
LINAGLIPTIN 2.5MG; METFORMIN HYDROCHLORIDE 500MG · TabletANDA208427-001 · Prescription
LINAGLIPTIN 2.5MG; METFORMIN HYDROCHLORIDE 850MG · TabletANDA208427-002 · Prescription
LINAGLIPTIN 2.5MG; METFORMIN HYDROCHLORIDE 1GM · TabletANDA208449-003 · Prescription
LINAGLIPTIN 2.5MG; METFORMIN HYDROCHLORIDE 500MG · TabletThis page
LINAGLIPTIN 2.5MG; METFORMIN HYDROCHLORIDE 850MG · TabletANDA208449-002 · Prescription
LINAGLIPTIN 2.5MG; METFORMIN HYDROCHLORIDE 1GM · TabletANDA208459-003 · Prescription
LINAGLIPTIN 2.5MG; METFORMIN HYDROCHLORIDE 500MG · Tablet

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA208459-001 · Prescription

LINAGLIPTIN 2.5MG; METFORMIN HYDROCHLORIDE 850MG · TabletANDA208459-002 · Prescription

LINAGLIPTIN 2.5MG; METFORMIN HYDROCHLORIDE 850MG · TabletANDA208336-002 · Prescription

LINAGLIPTIN 2.5MG; METFORMIN HYDROCHLORIDE 1GM · TabletANDA208336-003 · Prescription

LINAGLIPTIN 2.5MG; METFORMIN HYDROCHLORIDE 500MG · TabletANDA208336-001 · Prescription

LINAGLIPTIN 2.5MG; METFORMIN HYDROCHLORIDE 850MG · TabletANDA208473-002 · Tentative approval

LINAGLIPTIN 2.5MG; METFORMIN HYDROCHLORIDE 1GM · TabletANDA208473-003 · Tentative approval

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA208449.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Linagliptin and Metformin Hydrochloride
Active substance: linagliptin
Route: Oral
Dosage form: Tablet
Applicant: Zydus Pharms
Status: Prescription
FDA approval: 30 Mar 2023
Application: ANDA208449-001