Lorazepam
Approved
Approval ID
4f30bfb6-88fc-2b2d-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2020
Manufacturers
FDA
RedPharm Drug, Inc.
DUNS: 828374897
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 Code67296-1228
Application NumberANDA078203
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2020
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