Kimyrsa
These highlights do not include all the information needed to use KIMYRSA safely and effectively. See full prescribing information for KIMYRSA. KIMYRSA (oritavancin) for injection, for intravenous use Initial U.S. Approval: 2014
Approved
Approval ID
5e755c40-6e73-4572-b474-4d8a131693d1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 30, 2021
Manufacturers
FDA
Melinta Therapeutics, LLC
DUNS: 034132850
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oritavancin diphosphate
PRODUCT DETAILS
NDC Product Code70842-225
Application NumberNDA214155
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJuly 30, 2021
Generic Nameoritavancin diphosphate
INGREDIENTS (5)
ORITAVANCIN DIPHOSPHATEActive
Quantity: 1200 mg in 40 mL
Code: VL1P93MKZN
Classification: ACTIM
HYDROXYPROPYL BETADEXInactive
Code: 1I96OHX6EK
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT