Lyvispah
These highlights do not include all the information needed to use LYVISPAH safely and effectively. See full prescribing information for LYVISPAH. LYVISPAH (baclofen) oral granules Initial U.S. Approval: 1977
Approved
Approval ID
a7d2dc58-e167-4ebc-ac1d-932f000fb412
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 26, 2021
Manufacturers
FDA
Saol Therapeutics Inc
DUNS: 080040201
Products 3
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 Code70257-416
Application NumberNDA215422
Product Classification
M
Marketing Category
C73594
G
Generic Name
baclofen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2023
FDA Product Classification
INGREDIENTS (1)
BACLOFENActive
Quantity: 20 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB
baclofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70257-414
Application NumberNDA215422
Product Classification
M
Marketing Category
C73594
G
Generic Name
baclofen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2023
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 Code70257-412
Application NumberNDA215422
Product Classification
M
Marketing Category
C73594
G
Generic Name
baclofen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2023
FDA Product Classification
INGREDIENTS (1)
BACLOFENActive
Quantity: 5 mg in 1 1
Code: H789N3FKE8
Classification: ACTIB