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Cilostazol

These highlights do not include all the information needed to use CILOSTAZOL TABLETS safely and effectively. See full prescribing information for CILOSTAZOL TABLETS.CILOSTAZOL tablets, for oral useInitial U.S. Approval: 1999

Approved
Approval ID

507abc5a-c161-4d9e-87bc-57c38bc4b146

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 6, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

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

Cilostazol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-5329
Application NumberANDA077027
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cilostazol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 26, 2022
FDA Product Classification

INGREDIENTS (7)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CILOSTAZOLActive
Quantity: 50 mg in 1 1
Code: N7Z035406B
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Cilostazol - FDA Drug Approval Details