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Amlodipine Besylate

Amlodipine besylate tabletsThese highlights do not include all the information needed to use Amlodipine Besylate safely and effectively. See full prescribing information for Amlodipine Besylate. Amlodipine Besylate (Amlodipine Besylate) TABLET for ORAL use.Initial U.S. Approval: 2007

Approved
Approval ID

51e87d92-0c8a-46fa-a2d6-a8abf555201f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 20, 2013

Manufacturers
FDA

Aidarex Pharmaceuticals LLC

DUNS: 801503249

Products 3

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

Amlodipine Besylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code33261-826
Application NumberANDA077995
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2013
FDA Product Classification

INGREDIENTS (5)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 2.5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT

Amlodipine Besylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code33261-437
Application NumberANDA077995
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2013
FDA Product Classification

INGREDIENTS (5)

AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

Amlodipine Besylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code33261-535
Application NumberANDA077995
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2013
FDA Product Classification

INGREDIENTS (5)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

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Amlodipine Besylate - FDA Drug Approval Details