QUALAQUIN
These highlights do not include all the information needed to use QUALAQUIN safely and effectively. See full prescribing information for QUALAQUIN. QUALAQUIN (quinine sulfate) Capsules, USP for Oral useInitial U.S. Approval: 2005 BOXED WARNING (See full prescribing information for complete boxed warning)
Approved
Approval ID
ce2ffee3-3048-43a0-ac45-ee32ce0c4c33
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 18, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-595
Application NumberNDA021799
Product Classification
M
Marketing Category
C73594
G
Generic Name
QUININE SULFATE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 18, 2010
FDA Product Classification
INGREDIENTS (1)
QUININE SULFATEActive
Quantity: 324 mg in 1 1
Code: KF7Z0E0Q2B
Classification: ACTIB