LORAZEPAM
Lorazepam Tablet
Approved
Approval ID
84e74f60-4e4f-412f-a3ff-f3252838f371
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 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.
LORAZEPAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-143
Application NumberANDA072926
Product Classification
M
Marketing Category
C73584
G
Generic Name
LORAZEPAM
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2010
FDA Product Classification
INGREDIENTS (5)
LORAZEPAMActive
Quantity: 0.5 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
LORAZEPAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-584
Application NumberANDA072927
Product Classification
M
Marketing Category
C73584
G
Generic Name
LORAZEPAM
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2010
FDA Product Classification
INGREDIENTS (5)
LORAZEPAMActive
Quantity: 1 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT