MedPath

Lorazepam

Lorazepam Tablets, USP

Approved
Approval ID

67e14f73-3558-4ac0-a478-c0a9e1fad5dd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 23, 2011

Manufacturers
FDA

RedPharm Drug Inc.

DUNS: 008039641

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 Code67296-0042
Application NumberANDA071194
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2011
FDA Product Classification

INGREDIENTS (5)

LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LORAZEPAMActive
Quantity: 1 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Lorazepam - FDA Drug Approval Details