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Amlodipine Besylate

These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987 These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS, USP, safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS, USP.<br><br>AMLODIPINE BESYLATE TABLETS, USP for oral administration<br><br>Initial U.S. Approval: 1987

Approved
Approval ID

829aad05-7f21-41c2-b80b-2da793ae70d7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 15, 2021

Manufacturers
FDA

BIOMES PHARMACEUTICALS LLC

DUNS: 078644310

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 Code69150-113
Application NumberANDA077516
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2018
FDA Product Classification

INGREDIENTS (7)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
Amlodipine BesylateActive
Quantity: 2.5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

Amlodipine Besylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69150-114
Application NumberANDA077516
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2018
FDA Product Classification

INGREDIENTS (7)

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Amlodipine BesylateActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT

Amlodipine Besylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69150-115
Application NumberANDA077516
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amlodipine Besylate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2018
FDA Product Classification

INGREDIENTS (7)

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
Amlodipine BesylateActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT

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Amlodipine Besylate - FDA Drug Approval Details