Lorazepam
Approved
Approval ID
9f495605-0959-442c-8636-9c2d2f93bdff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 18, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-3566
Application NumberANDA074300
Product Classification
M
Marketing Category
C73584
G
Generic Name
lorazepam
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJune 18, 2010
FDA Product Classification
INGREDIENTS (3)
LORAZEPAMActive
Quantity: 2 mg in 1 mL
Code: O26FZP769L
Classification: ACTIM
POLYETHYLENE GLYCOLInactive
Quantity: 0.18 mL in 1 mL
Code: 3WJQ0SDW1A
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 20 mg in 1 mL
Code: LKG8494WBH
Classification: IACT