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Flecainide Acetate

Flecainide Acetate Tablets USPRx only

Approved
Approval ID

1a2a5e08-2697-4a00-94fe-de07148acbd9

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.

Flecainide Acetate

PRODUCT DETAILS

NDC Product Code50090-2968
Application NumberANDA075882
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 16, 2017
Generic NameFlecainide Acetate

INGREDIENTS (7)

FLECAINIDE ACETATEActive
Quantity: 100 mg in 1 1
Code: M8U465Q1WQ
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
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Flecainide Acetate - FDA Approval | MedPath