BACLOFEN
These highlights do not include all the information needed to use BACLOFEN ORAL SUSPENSION safely and effectively. See full prescribing information for BACLOFEN ORAL SUSPENSION. BACLOFEN oral suspension, for oral use Initial U.S. Approval: 1977
Approved
Approval ID
9fad5ffc-afae-4c92-a672-ee636df45bc5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 16, 2023
Manufacturers
FDA
Slayback Pharma LLC
DUNS: 967770848
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 Code71225-140
Application NumberANDA217252
Product Classification
M
Marketing Category
C73584
G
Generic Name
BACLOFEN
Product Specifications
Route of AdministrationORAL
Effective DateJune 16, 2023
FDA Product Classification
INGREDIENTS (10)
BACLOFENActive
Quantity: 5 mg in 1 mL
Code: H789N3FKE8
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT