Amlodipine and Olmesartan Medoxomil

These highlights do not include all the information needed to use AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS. AMLODIPINE and OLMESARTAN MEDOXOMIL tablets, for oral useInitial U.S. Approval: 2007

Approved

Approval ID

c531fceb-09aa-492b-a5a3-2b004e9eadda

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 10, 2018

Manufacturers

FDA

ScieGen Pharmaceuticals, Inc

DUNS: 079391286

Products 4

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

Amlodipine and Olmesartan Medoxomil

PRODUCT DETAILS

NDC Product Code50228-368

Application NumberANDA209010

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateDecember 10, 2018

Generic NameAmlodipine and Olmesartan Medoxomil

INGREDIENTS (15)

OLMESARTAN MEDOXOMILActive

Quantity: 40 mg in 1 1

Code: 6M97XTV3HD

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

Amlodipine and Olmesartan Medoxomil

PRODUCT DETAILS

NDC Product Code50228-367

Application NumberANDA209010

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateDecember 10, 2018

Generic NameAmlodipine and Olmesartan Medoxomil

INGREDIENTS (14)

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

OLMESARTAN MEDOXOMILActive

Quantity: 20 mg in 1 1

Code: 6M97XTV3HD

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

Amlodipine and Olmesartan Medoxomil

PRODUCT DETAILS

NDC Product Code50228-365

Application NumberANDA209010

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateDecember 10, 2018

Generic NameAmlodipine and Olmesartan Medoxomil

INGREDIENTS (12)

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

OLMESARTAN MEDOXOMILActive

Quantity: 20 mg in 1 1

Code: 6M97XTV3HD

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

Amlodipine and Olmesartan Medoxomil

PRODUCT DETAILS

NDC Product Code50228-366

Application NumberANDA209010

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateDecember 10, 2018

Generic NameAmlodipine and Olmesartan Medoxomil

INGREDIENTS (13)

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

OLMESARTAN MEDOXOMILActive

Quantity: 40 mg in 1 1

Code: 6M97XTV3HD

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

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Amlodipine and Olmesartan Medoxomil

Products 4

Amlodipine and Olmesartan Medoxomil

PRODUCT DETAILS

INGREDIENTS (15)

Amlodipine and Olmesartan Medoxomil

PRODUCT DETAILS

INGREDIENTS (14)

Amlodipine and Olmesartan Medoxomil

PRODUCT DETAILS

INGREDIENTS (12)

Amlodipine and Olmesartan Medoxomil

PRODUCT DETAILS

INGREDIENTS (13)

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