amlodipine besylate 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 use Initial U.S. Approval: 2007

Approved

Approval ID

a855ce60-6918-490a-9158-3be5a0ef76b5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 14, 2019

Manufacturers

FDA

Accord Healthcare Inc.

DUNS: 604222237

Products 4

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

amlodipine besylate and olmesartan medoxomil

PRODUCT DETAILS

NDC Product Code16729-394

Application NumberANDA209600

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateAugust 14, 2019

Generic Nameamlodipine besylate and olmesartan medoxomil

INGREDIENTS (13)

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

OLMESARTAN MEDOXOMILActive

Quantity: 20 mg in 1 1

Code: 6M97XTV3HD

Classification: ACTIB

amlodipine besylate and olmesartan medoxomil

PRODUCT DETAILS

NDC Product Code16729-393

Application NumberANDA209600

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateAugust 14, 2019

Generic Nameamlodipine besylate and olmesartan medoxomil

INGREDIENTS (12)

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

OLMESARTAN MEDOXOMILActive

Quantity: 40 mg in 1 1

Code: 6M97XTV3HD

Classification: ACTIB

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

amlodipine besylate and olmesartan medoxomil

PRODUCT DETAILS

NDC Product Code16729-392

Application NumberANDA209600

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateAugust 14, 2019

Generic Nameamlodipine besylate and olmesartan medoxomil

INGREDIENTS (11)

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

OLMESARTAN MEDOXOMILActive

Quantity: 20 mg in 1 1

Code: 6M97XTV3HD

Classification: ACTIB

amlodipine besylate and olmesartan medoxomil

PRODUCT DETAILS

NDC Product Code16729-395

Application NumberANDA209600

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateAugust 14, 2019

Generic Nameamlodipine besylate and olmesartan medoxomil

INGREDIENTS (13)

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL 4000Inactive

Code: 4R4HFI6D95

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

OLMESARTAN MEDOXOMILActive

Quantity: 40 mg in 1 1

Code: 6M97XTV3HD

Classification: ACTIB

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amlodipine besylate and olmesartan medoxomil

Products 4

amlodipine besylate and olmesartan medoxomil

PRODUCT DETAILS

INGREDIENTS (13)

amlodipine besylate and olmesartan medoxomil

PRODUCT DETAILS

INGREDIENTS (12)

amlodipine besylate and olmesartan medoxomil

PRODUCT DETAILS

INGREDIENTS (11)

amlodipine besylate and olmesartan medoxomil

PRODUCT DETAILS

INGREDIENTS (13)

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