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
1f66fba7-4026-4504-918d-4c88f2835cc0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 23, 2013
Manufacturers
FDA
AR Scientific Inc.
DUNS: 606563521
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 Code13310-153
Application NumberNDA021799
Product Classification
M
Marketing Category
C73594
G
Generic Name
Quinine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 21, 2012
FDA Product Classification
INGREDIENTS (4)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Quinine SulfateActive
Quantity: 324 mg in 1 1
Code: KF7Z0E0Q2B
Classification: ACTIB
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT