NDC 70842-225

Kimyrsa

Oritavancin Diphosphate

Kimyrsa is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Melinta Therapeutics, Llc. The primary component is Oritavancin Diphosphate.

Product ID70842-225_177809df-e595-441f-98cb-90f60a3bc11e
NDC70842-225
Product TypeHuman Prescription Drug
Proprietary NameKimyrsa
Generic NameOritavancin Diphosphate
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2021-03-23
Marketing CategoryNDA /
Application NumberNDA214155
Labeler NameMelinta Therapeutics, LLC
Substance NameORITAVANCIN DIPHOSPHATE
Active Ingredient Strength1200 mg/40mL
Pharm ClassesLipoglycopeptide Antibacterial [EPC],Lipoglycopeptides [EXT],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70842-225-01

1 VIAL in 1 CARTON (70842-225-01) > 40 mL in 1 VIAL
Marketing Start Date2021-03-23
NDC Exclude FlagN
Sample Package?N

Drug Details


Trademark Results [Kimyrsa]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KIMYRSA
KIMYRSA
90039970 not registered Live/Pending
Melinta Therapeutics, Inc.
2020-07-07
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