Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Preferred Pharmaceuticals Inc.
791119022
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals Inc.
791119022
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
68788-7355Application Number
ANDA203572Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 25, 2023MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
LorazepamActive
Code: O26FZP769LClass: ACTIBQuantity: 0.5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT