QUININE SULFATE
These highlights do not include all the information needed to use QUININE Sulfate safely and effectively. See full prescribing information for QUININE Sulfate. QUININE Sulfate Capsules, USP for oral use. Initial U.S. Approval: 2005
Approved
Approval ID
b2f73c64-b92c-49bf-ad39-e32ac83e4d3d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 28, 2019
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
QUININE SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-238
Application NumberANDA204372
Product Classification
M
Marketing Category
C73584
G
Generic Name
QUININE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 28, 2019
FDA Product Classification
INGREDIENTS (6)
QUININE SULFATEActive
Quantity: 324 mg in 1 1
Code: KF7Z0E0Q2B
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT