Baclofen
Approved
Approval ID
31804ce6-5028-4f63-b737-ddb4275b9599
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2011
Manufacturers
FDA
Med Health Pharma, LLC
DUNS: 962603812
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 Code51138-007
Application NumberANDA073092
Product Classification
M
Marketing Category
C73584
G
Generic Name
Baclofen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2011
FDA Product Classification
INGREDIENTS (1)
BaclofenActive
Quantity: 10 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
Baclofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51138-008
Application NumberANDA073092
Product Classification
M
Marketing Category
C73584
G
Generic Name
Baclofen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2011
FDA Product Classification
INGREDIENTS (1)
BaclofenActive
Quantity: 20 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB