MedPath

Losartan Potassium

LOSARTAN POTASSIUM TABLETS USP

Approved
Approval ID

69605072-f130-4054-95b0-ff3c34554fb9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 21, 2010

Manufacturers
FDA

MedVantx, Inc.

DUNS: 806427725

Products 1

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

Losartan Potassium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66116-415
Application NumberANDA090382
Product Classification
M
Marketing Category
C73584
G
Generic Name
Losartan Potassium
Product Specifications
Route of AdministrationORAL
Effective DateJuly 15, 2010
FDA Product Classification

INGREDIENTS (10)

TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LOSARTAN POTASSIUMActive
Quantity: 50 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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