Gloperba
These highlights do not include all the information needed to use GLOPERBA safely and effectively. See full prescribing information for GLOPERBA. GLOPERBA (colchicine) Oral Solution Initial U.S. Approval: 1961
Approved
Approval ID
467cd83f-d695-4040-9434-10e80b4271da
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2023
Manufacturers
FDA
Scilex Pharmaceuticals, Inc.
DUNS: 078286225
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Colchicine
PRODUCT DETAILS
NDC Product Code69557-222
Application NumberNDA210942
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 1, 2022
Generic NameColchicine
INGREDIENTS (11)
ColchicineActive
Quantity: 0.6 mg in 5 mL
Code: SML2Y3J35T
Classification: ACTIB
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
sucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CherryInactive
Code: BUC5I9595W
Classification: IACT