ATIVAN
Approved
Approval ID
ba6ce50e-c5a9-47ca-9803-a1ed82172b0e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2011
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 Code16590-813
Application NumberNDA017794
Product Classification
M
Marketing Category
C73594
G
Generic Name
LORAZEPAM
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2009
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LORAZEPAMActive
Quantity: 1 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
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 Code16590-937
Application NumberNDA017794
Product Classification
M
Marketing Category
C73594
G
Generic Name
LORAZEPAM
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2009
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LORAZEPAMActive
Quantity: 0.5 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT