Lorazepam
Lorazepam Tablets, USP CIV Rx only
Approved
Approval ID
3460182a-31e4-4628-b439-158a37f7a836
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2014
Manufacturers
FDA
Excellium Pharmaceutical Inc.
DUNS: 011769192
Products 1
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 Code64125-906
Application NumberANDA078203
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2012
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
LORAZEPAMActive
Quantity: 2 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT