Lorazepam
LORAZEPAM INTENSOL™ Oral Concentrate USP2 mg per mL
Approved
Approval ID
ee9e95a6-a9d7-43c1-ac3c-c9dc4b390760
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 18, 2009
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 Code54868-6010
Application NumberANDA073079
Product Classification
M
Marketing Category
C73584
G
Generic Name
lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateJune 17, 2010
FDA Product Classification
INGREDIENTS (3)
LORAZEPAMActive
Quantity: 2 mg in 1 mL
Code: O26FZP769L
Classification: ACTIM
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT