Quinidine Sulfate
Quinidine Sulfate Tablets, USP 200 mg and 300 mg
Approved
Approval ID
a10b6ded-4fe0-4059-bd77-c45acc3c876d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2019
Manufacturers
FDA
Eon Labs, Inc.
DUNS: 012656273
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Quinidine Sulfate
PRODUCT DETAILS
NDC Product Code0185-1047
Application NumberANDA088072
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 13, 2019
Generic NameQuinidine Sulfate
INGREDIENTS (5)
QUINIDINE SULFATEActive
Quantity: 300 mg in 1 1
Code: J13S2394HE
Classification: ACTIB
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Quinidine Sulfate
PRODUCT DETAILS
NDC Product Code0185-4346
Application NumberANDA088072
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 13, 2019
Generic NameQuinidine Sulfate
INGREDIENTS (5)
QUINIDINE SULFATEActive
Quantity: 200 mg in 1 1
Code: J13S2394HE
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT