Lorazepam

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

Contract Pharmacy Services-PA

DUNS: 945429777

Effective Date

March 4, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Lorazepam(2 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Contract Pharmacy Services-PA

DUNS Number

945429777

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

67046-888

Application Number

ANDA203572

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 4, 2020

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLACRILIN POTASSIUMInactive

Code: 0BZ5A00FQUClass: IACT

Code: O26FZP769LClass: ACTIBQuantity: 2 mg in 1 1

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.