FDA Product

LORAZEPAM

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

LORAZEPAM

FDA Product Code

70518-3855

Regulatory Information

NDC Product Code

70518-3855

Application Number

ANDA203572

Marketing Category

C73584

Effective Date

April 2, 2024

Territorial Authority

USA

FDA Title

Lorazepam Tablets, USP CIV Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerREMEDYREPACK INC.

DUNS Number

829572556

Active Ingredients

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

POLACRILIN POTASSIUM

Code: 0BZ5A00FQU

Class Code: IACT

Quantity: 0.5 mg in 1 1

Code: O26FZP769L

Class Code: ACTIB

Active Moieties

LORAZEPAM

Code: O26FZP769L

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