Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Amneal Pharmaceuticals of New York, LLC
Amneal Pharmaceuticals LLC
831227801
Products3
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
65162-015Application Number
ANDA078826Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 30, 2022LorazepamActive
Code: O26FZP769LClass: ACTIBQuantity: 0.5 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
Lorazepam
Product Details
NDC Product Code
65162-017Application Number
ANDA078826Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 30, 2022LorazepamActive
Code: O26FZP769LClass: ACTIBQuantity: 2 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
Lorazepam
Product Details
NDC Product Code
65162-018Application Number
ANDA078826Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 30, 2022LorazepamActive
Code: O26FZP769LClass: ACTIBQuantity: 1 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT