Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Hikma Pharmaceuticals USA Inc.
001230762
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Midazolam
Product Details
NDC Product Code
0641-6209Application Number
ANDA075243Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
April 7, 2023SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.1 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 10 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
MidazolamActive
Code: W7TTW573JJClass: ACTIMQuantity: 1 mg in 1 mL
Midazolam
Product Details
NDC Product Code
0641-6210Application Number
ANDA075243Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
April 7, 2023MidazolamActive
Code: W7TTW573JJClass: ACTIMQuantity: 1 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.1 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 10 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Midazolam
Product Details
NDC Product Code
0641-6211Application Number
ANDA075243Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
April 7, 2023SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.1 mg in 1 mL
MidazolamActive
Code: W7TTW573JJClass: ACTIMQuantity: 5 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 10 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT