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Medicines
United States
Insulin glargine

FDA 2000

Insulin glargine

Lantus

500UNITS/5ML InjectionUnited StatesNot marketedAuthorised 20 Apr 2000

Open in the registerAsk Osler about it

On this page

In other countries
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

LantusBrazil · Sanofi Medley Farmacêutica Ltda.Same brand
LantusBrazil · Sanofi-Aventis Farmacêutica LtdaSame brand
LantusCanada · 100 UNIT / ML · Solution · Sanofi-Aventis Canada INCSame brand
LantusCanada · 100 UNIT / ML · Solution · Sanofi-Aventis Canada INCSame brand
LantusCanada · 100 UNIT / ML · Solution · Sanofi-Aventis Canada INCSame brand
Lantus 100 Unidades/ML Solucion Inyectable en Un CartuchoSpain · 100 UI · solución inyectable en cartucho · Sanofi-Aventis Deutschland GmbhSame brand
Lantus 100 Unidades/ML Solucion Inyectable en Un VialSpain · 100 UI · solución inyectable · Sanofi-Aventis Deutschland Gmbh

More with the same substance on this register

BasaglarInsulin glargine · 300 UNITS/3ML · solutionUnited States
RezvoglarInsulin glargine · 3ML · injectableUnited States

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.

Same brand

🇪🇸Lantus Solostar 100 Unidades/ML Solucion Inyectable en Pluma PrecargadaSpain · 100 U · solución inyectable en pluma precargada · Sanofi-Aventis Deutschland GmbhSame brand

🇪🇺LantusEuropean Union · sanofi-aventis Deutschland GmbHSame brand

🇭🇷LantusCroatiaSame brand

🇮🇹LantusItaly · Soluzione iniettabile · Sanofi-Aventis Deutschland GMBHSame brand

🇳🇱Lantus 100 eenheden/ml oplossing voor injectie in een injectieflaconNetherlands · Oplossing voor injectie · Sanofi-Aventis Deutschland GmbHSame brand

🇳🇱Lantus 100 eenheden/ml oplossing voor injectie in een patroonNetherlands · Oplossing voor injectie · Sanofi-Aventis Deutschland GmbHSame brand

🇳🇱Lantus SoloStar 100 eenheden/ml oplossing voor injectie in voorgevulde penNetherlands · Oplossing voor injectie · Sanofi-Aventis Deutschland GmbHSame brand

🇳🇿LantusNew Zealand · Inj 100 u per ml, 10 mlSame brand

🇳🇿LantusNew Zealand · Inj 100 u per ml, 3 mlSame brand

🇳🇿LantusNew Zealand · Inj 100 u per ml, 3 ml cartridgeSame brand

🇷🇴LANTUS 100U/mlRomania · 100U/ml · sol. inj. in cartus · SanofiSame brand

🇷🇴LANTUS SoloStarRomania · 100U/ml · sol. inj. in stilou injector preumplut · SanofiSame brand

🇷🇸Lantus® SoloStar®Serbia · 100j./mL · rastvor za injekciju u napunjenom injekcionom penu · Amicus SRB D.O.O.Same brand

🇸🇦Lantus 100 I.U - ML VialSaudi Arabia · sanofi-aventisSame brand

🇸🇦Lantus Solostar 100I.U-ML Disposable PenSaudi Arabia · sanofi-aventisSame brand

🇸🇦Lantus 100 I.U - ML CartridgeSaudi Arabia · sanofi-aventisSame brand

🇸🇬LANTUS 100 Units/ml Solution for injection in a vialSingapore · 100 iu/ml · injection · Sanofi-Aventis Singapore Pte. LTD.Same brand

🇸🇬Lantus SoloStar 100 Units/ml Solution for injection in a pre-filled penSingapore · 100 iu/ml · injection, solution · Sanofi-Aventis Singapore Pte. LTD.Same brand

🇮🇹AbasaglarItaly · Soluzione iniettabile · Eli Lilly Nederland B.V.Same form

🇮🇹OndibtaItaly · Soluzione iniettabile in penna pre-riempita · Gan & Lee Pharmaceuticals Europe GMBHSame form

🇷🇴AbasaglarRomania · 100UI/ml · sol inj. · Eli Lilly Nederland B.V.Same form

🇷🇸Semglee®Serbia · 100j./mL · rastvor za injekciju u napunjenom injekcionom penu · Evropa Lek Pharma D.O.O. BeogradSame form

🇷🇸Toujeo®Serbia · 300j./mL · rastvor za injekciju u napunjenom injekcionom penu · Amicus SRB D.O.O.Same form

🇸🇬Semglee™ Solution for Injection in A Prefilled Pen 100U/MLSingapore · 3.64 mg/ml · injection, solution · Cedar Pharmaceuticals Pte. LTD.Same form

🇧🇷BasaglarBrazil · Eli Lilly do Brasil LtdaSame substance

🇪🇺Abasaglar (previously Abasria)European Union · Eli Lilly Nederland B.V.Same substance

🇪🇺OndibtaEuropean Union · Gan & Lee Pharmaceuticals Europe GmbHSame substance

🇭🇷AbasaglarCroatiaSame substance

🇭🇷SemgleeCroatiaSame substance

Documents

The official texts, at the regulator.

Register entryFDA

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

U.S. Food and Drug Administration

FDA Purple Book, September 2026 release; acquired 2026-10-10T15:29:54.330165+00:00; exact source fields retained with source-key projections.

Licence: FDA-created structured factual administrative metadata; public-domain policy with third-party exceptions · Added 11 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

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

Active substance: Insulin glargine
Strength: 500UNITS/5ML
Dosage form: Injection
Route: Subcutaneous
Register: United States (FDA)
Status: Not marketed
Status in the register: Licensed / Disc
Authorised: 20 Apr 2000
Registration: BLA 021081
Marketing authorisation holder: Sanofi-Aventis U.S. LLC
Procedure: 351(a)
Supply: Disc

FDA

SemgleeInsulin glargine · 10ML, 3ML · injectable🇺🇸United States

FDABasaglarInsulin glargine · 300UNITS/3ML · Injection🇺🇸United States

FDALanglaraInsulin glargine · 100UNITS/ML · injectable🇺🇸United States

FDASemgleeInsulin glargine · 100 UNITS/ML · injectable🇺🇸United States

FDALantusInsulin glargine · 300UNITS/3ML · Injection🇺🇸United States

FDASemgleeInsulin glargine · 300UNITS/3ML · Injection🇺🇸United StatesWithdrawn