Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Cidara Therapeutics, Inc.
025485700
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Patheon Italia S.p.A.
Melinta Therapeutics, LLC
Cidara Therapeutics, Inc.
338336589
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
REZZAYO
Product Details
NDC Product Code
70842-240Application Number
NDA217417Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
June 8, 2022RezafunginActive
Code: G013B5478JClass: ACTIBQuantity: 200 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
HISTIDINEInactive
Code: 4QD397987EClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT