Application Nr Approved Date Route Status External Links
ANDA078243 2010-10-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Hypertension: Losartan Potassium Tablets Are Indicated For The Treatment Of Hypertension. It May Be Used Alone Or In Combination With Other Antihypertensive Agents, Including Diuretics. Hypertensive Patients With Left Ventricular Hypertrophy: Losartan Potassium Tablets Are Indicated To Reduce The Risk Of Stroke In Patients With Hypertension And Left Ventricular Hypertrophy, But There Is Evidence That This Benefit Does Not Apply To Black Patients (see Precautions, Race And Clinical Pharmacology, Pharmacodynamics And Clinical Effects, Reduction In The Risk Of Stroke, Race). Nephropathy In Type 2 Diabetic Patients Losartan Potassium Tablets Are Indicated For The Treatment Of Diabetic Nephropathy With An Elevated Serum Creatinine And Proteinuria (urinary Albumin To Creatinine Ratio ≥ 300 Mg/g) In Patients With Type 2 Diabetes And A History Of Hypertension. In This Population, Losartan Potassium Reduces The Rate Of Progression Of Nephropathy As Measured By The Occurrence Of Doubling Of Serum Creatinine Or End Stage Renal Disease (need For Dialysis Or Renal Transplantation) (see Clinical Pharmacology, Pharmacodynamics And Clinical Effects).

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Losartan Potassium LOSARTAN POTASSIUM ZINC3873160

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