Clinical Trials

Find trials by condition, location & phase

Drug Monographs

Browse drug monographs and information

Explore organizations and their profiles

Latest updates on trials and healthcare

Approved products by global authorities

AI-Powered Research

Discover powerful insights with advanced AI analysis tools for clinical trials.

Premium Access

Get unlimited access to our comprehensive pharmaceutical database and analytics.

FDA Approval

OLMESARTAN MEDOXOMIL

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Lifestar Pharma LLC

DUNS: 080268943

Effective Date

December 19, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Olmesartan(40 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

UMEDICA LABORATORIES PRIVATE LIMITED

Labeler

Lifestar Pharma LLC

DUNS Number

920635096

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

OLMESARTAN MEDOXOMIL

Product Details

NDC Product Code

70756-810

Application Number

ANDA207135

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 19, 2023

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive

Code: 2165RE0K14Class: IACT

HYDROXYPROPYL CELLULOSE (TYPE L)Inactive

Code: UKE75GEA7FClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

OlmesartanActive

Code: 6M97XTV3HDClass: ACTIBQuantity: 40 mg in 1 1

OLMESARTAN MEDOXOMIL

Product Details

NDC Product Code

70756-808

Application Number

ANDA207135

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 19, 2023

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive

Code: 2165RE0K14Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

OlmesartanActive

Code: 6M97XTV3HDClass: ACTIBQuantity: 5 mg in 1 1

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

HYDROXYPROPYL CELLULOSE (TYPE L)Inactive

Code: UKE75GEA7FClass: IACT

OLMESARTAN MEDOXOMIL

Product Details

NDC Product Code

70756-809

Application Number

ANDA207135

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 19, 2023

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive

Code: 2165RE0K14Class: IACT

HYDROXYPROPYL CELLULOSE (TYPE L)Inactive

Code: UKE75GEA7FClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

OlmesartanActive

Code: 6M97XTV3HDClass: ACTIBQuantity: 20 mg in 1 1

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy