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Conjupri

These highlights do not include all the information needed to use CONJUPRIsafely and effectively. See full prescribing information for CONJUPRI. CONJUPRI (levamlodipine) tablets, for oral use.Initial U.S. Approval: 2019

Approved
Approval ID

c3cca66e-348a-43e8-8f96-e995104dae3d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 14, 2023

Manufacturers
FDA

CSPC Ouyi Pharmaceutical Co. Ltd

DUNS: 421303775

Products 2

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

levamlodipine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24075-0411
Application NumberNDA212895
Product Classification
M
Marketing Category
C73594
G
Generic Name
levamlodipine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2023
FDA Product Classification

INGREDIENTS (6)

LEVAMLODIPINE MALEATEActive
Quantity: 2.5 mg in 2.5 mg
Code: 12WW9T2ITA
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BETADEXInactive
Code: JV039JZZ3A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

levamlodipine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24075-0413
Application NumberNDA212895
Product Classification
M
Marketing Category
C73594
G
Generic Name
levamlodipine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2023
FDA Product Classification

INGREDIENTS (6)

LEVAMLODIPINE MALEATEActive
Quantity: 5 mg in 5 mg
Code: 12WW9T2ITA
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BETADEXInactive
Code: JV039JZZ3A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

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Conjupri - FDA Drug Approval Details