Quinidine Gluconate
QUINIDINE GLUCONATE EXTENDED-RELEASE TABLETS USP
Approved
Approval ID
5023f053-fcc4-4c2c-aa59-9ec198ad185e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2018
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Quinidine Gluconate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53489-141
Application NumberANDA089338
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinidine Gluconate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2018
FDA Product Classification
INGREDIENTS (1)
Quinidine GluconateActive
Quantity: 324 mg in 1 1
Code: R6875N380F
Classification: ACTIB