Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Leading Pharma, LLC
079575060
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Leading Pharma, LLC
Leading Pharma, LLC
Leading Pharma, LLC
079575060
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
69315-906Application Number
ANDA078203Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 10, 2023LorazepamActive
Code: O26FZP769LClass: ACTIBQuantity: 2 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
Lorazepam
Product Details
NDC Product Code
69315-905Application Number
ANDA078203Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 10, 2023MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
LorazepamActive
Code: O26FZP769LClass: ACTIBQuantity: 1 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
Lorazepam
Product Details
NDC Product Code
69315-904Application Number
ANDA078203Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 10, 2023LorazepamActive
Code: O26FZP769LClass: ACTIBQuantity: 0.5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT