Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Exela Pharma Sciences, LLC
831274399
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Siegfried Hameln GmbH
Exela Pharma Sciences, LLC
Exela Pharma Sciences, LLC
315869123
Exela Pharma Sciences, LLC
Exela Pharma Sciences, LLC
Exela Pharma Sciences, LLC
831274399
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Akovaz
Product Details
NDC Product Code
51754-4250Application Number
NDA208289Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
November 27, 2020EphedrineActive
Code: U6X61U5ZEGClass: ACTIBQuantity: 5 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
Akovaz
Product Details
NDC Product Code
51754-4200Application Number
NDA208289Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
November 27, 2020EphedrineActive
Code: U6X61U5ZEGClass: ACTIBQuantity: 50 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT