BACLOFEN
Baclofen Oral Solution These highlights do not include all the information needed to use Baclofen Oral Solution safely and effectively. See full prescribing information for Baclofen Oral Solution. Baclofen Oral Solution Initial U.S. Approval: 1977
Approved
Approval ID
6cc2773b-cb64-48e9-a69b-e457b82cb2d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 28, 2022
Manufacturers
FDA
Palmetto Pharmaceuticals Inc.
DUNS: 963291864
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Baclofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68134-401
Application NumberNDA208193
Product Classification
M
Marketing Category
C73605
G
Generic Name
Baclofen
Product Specifications
Route of AdministrationORAL
Effective DateMarch 28, 2022
FDA Product Classification
INGREDIENTS (8)
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BACLOFENActive
Quantity: 5 mg in 5 mL
Code: H789N3FKE8
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT