Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Steriscience Pte. Limited
659844097
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
82449-207Application Number
ANDA090316Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
December 13, 2023EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
MidazolamActive
Code: W7TTW573JJClass: ACTIMQuantity: 1 mg in 1 mL
Midazolam
Product Details
NDC Product Code
82449-208Application Number
ANDA090316Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
December 13, 2023BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
MidazolamActive
Code: W7TTW573JJClass: ACTIMQuantity: 5 mg in 1 mL
Midazolam
Product Details
NDC Product Code
82449-209Application Number
ANDA090316Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
December 13, 2023SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
MidazolamActive
Code: W7TTW573JJClass: ACTIMQuantity: 5 mg in 1 mL