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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
Effective Date
July 20, 2018
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.

Medsource Pharmaceuticals

Medsource Pharmaceuticals

833685915

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
45865-499
Application Number
ANDA071403
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 20, 2018
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
LorazepamActive
Code: O26FZP769LClass: ACTIBQuantity: 0.5 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
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