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FDA Approval

Losartan Potassium

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

FDA Approval Summary

Company

Solco Healthcare US, LLC

DUNS: 828343017

Effective Date

September 15, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Losartan(100 mg in 1 1)

Products3

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

Losartan Potassium

Product Details

NDC Product Code

43547-362

Application Number

ANDA091497

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 15, 2021

Ingredients

Code: 3ST302B24AClass: ACTIBQuantity: 100 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

Losartan Potassium

Product Details

NDC Product Code

43547-360

Application Number

ANDA091497

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 15, 2021

Ingredients

Code: 3ST302B24AClass: ACTIBQuantity: 25 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

Losartan Potassium

Product Details

NDC Product Code

43547-361

Application Number

ANDA091497

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 15, 2021

Ingredients

Code: 3ST302B24AClass: ACTIBQuantity: 50 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

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