Baclofen (Intrathecal)
Baclofen Injection (Intrathecal), USP
Approved
Approval ID
11ba5575-a856-414a-89f8-17f3a01de55b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2023
Manufacturers
FDA
MAIA Pharmaceuticals, Inc.
DUNS: 079211845
Products 2
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 Code70511-122
Application NumberANDA210048
Product Classification
M
Marketing Category
C73584
G
Generic Name
baclofen
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateNovember 8, 2023
FDA Product Classification
INGREDIENTS (3)
BACLOFENActive
Quantity: 500 ug in 1 mL
Code: H789N3FKE8
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Baclofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70511-124
Application NumberANDA210048
Product Classification
M
Marketing Category
C73584
G
Generic Name
Baclofen
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateNovember 8, 2023
FDA Product Classification
INGREDIENTS (3)
BACLOFENActive
Quantity: 2000 ug in 1 mL
Code: H789N3FKE8
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT