MedPath
FDA Product

Losartan Potassium

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Losartan Potassium

0615-7960

Regulatory Information

0615-7960

ANDA078243

C73584

August 12, 2019

USA

These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. for oral use Initial U.S. Approval: 1995

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

NCS HealthCare of KY, Inc dba Vangard Labs

050052943

Active Ingredients

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

LOSARTAN POTASSIUM

Quantity: 100 mg in 1 1

Code: 3ST302B24A

Class Code: ACTIB

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

Code: 2165RE0K14

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

LOSARTAN

Code: JMS50MPO89

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