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FDA Approval

Lorazepam

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

FDA Approval Summary

Company
Contract Pharmacy Services-PA
DUNS: 945429777
Effective Date
September 14, 2017
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Lorazepam(0.5 mg in 1 1)

Manufacturing Establishments1

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

Coupler Enterprises

Contract Pharmacy Services-PA

945429777

Products1

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

Lorazepam

Product Details

NDC Product Code
67046-924
Application Number
ANDA078203
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 14, 2017
LorazepamActive
Code: O26FZP769LClass: ACTIBQuantity: 0.5 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
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