BACLOFEN
Approved
Approval ID
455170de-dd54-4f56-9eb1-ffe5cfbdc0e2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-026
Application NumberANDA072824
Product Classification
M
Marketing Category
C73584
G
Generic Name
BACLOFEN
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2010
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BACLOFENActive
Quantity: 10 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
BACLOFEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-027
Application NumberANDA072828
Product Classification
M
Marketing Category
C73584
G
Generic Name
BACLOFEN
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2010
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
BACLOFENActive
Quantity: 20 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT