Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
BioTime Inc.
781078977
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Hospira, Inc.
Hospira, Inc.
BioTime Inc.
093132819
Fresenius Kabi Austria GmbH
Hospira, Inc.
BioTime Inc.
303448575
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hextend
Product Details
NDC Product Code
0409-1555Application Number
BN200952Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
February 15, 2023Hydroxyethyl StarchActive
Code: 875Y4127EAClass: ACTIBQuantity: 6 g in 100 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10Class: IACT
SODIUM LACTATEInactive
Code: TU7HW0W0QTClass: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5MClass: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083GClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9OClass: IACT