Is Melinta Therapeutics, LLC FDA approved?

Melinta Therapeutics, LLC holds no registered establishment of its own; 11 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Melinta Therapeutics, LLC make?

11 products are listed under Melinta Therapeutics, LLC in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution; tablet, extended release; injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Melinta Therapeutics, LLC

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 11
Live patents: 8
Countries: 0

Catalogue

Drug listings by form and route

11 active NDC listings: 11 human prescription drug. By marketing category: NDA 11.

Dosage form	NDCs
injection, powder, lyophilized, for solution	4
tablet, extended release	4
injection	1
injection, powder, for solution	1
tablet	1

Route	NDCs
intravenous	6
oral	5

Labeller name on the listing	NDCs
melinta therapeutics, llc	11

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
12514899	KIMYRSA, ORBACTIVoritavancin diphosphate	use	Aug 2029
8420592	KIMYRSA, ORBACTIVoritavancin diphosphate	use	Aug 2029
9682061	KIMYRSA, ORBACTIVoritavancin diphosphate	use	Apr 2030
9649352	KIMYRSA, ORBACTIVoritavancin diphosphate	substance, product	Jul 2035

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Baxdela	delafloxacin meglumine	tablet, oral	70842-101NDA
Baxdela	delafloxacin meglumine	injection, powder, lyophilized, for solution, intravenous	70842-102NDA
Kimyrsa	oritavancin diphosphate	injection, powder, lyophilized, for solution, intravenous	70842-225NDA
Minocin	minocycline hydrochloride	injection, intravenous	70842-160NDA
Orbactiv	oritavancin	injection, powder, lyophilized, for solution, intravenous	70842-140NDA
REZZAYO	rezafungin	injection, powder, lyophilized, for solution, intravenous	70842-240NDA
TOPROL XL	Metoprolol Succinate	tablet, extended release, oral	70842-110NDA
TOPROL XL	Metoprolol Succinate	tablet, extended release, oral	70842-111NDA
TOPROL XL	Metoprolol Succinate	tablet, extended release, oral	70842-112NDA
TOPROL XL	Metoprolol Succinate	tablet, extended release, oral	70842-113NDA
VABOMERE	Meropenem-Vaborbactam	injection, powder, for solution, intravenous	70842-120NDA

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Enquiry

Common questions

Is Melinta Therapeutics, LLC FDA approved?: Melinta Therapeutics, LLC holds no registered establishment of its own; 11 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Melinta Therapeutics, LLC make?: 11 products are listed under Melinta Therapeutics, LLC in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution; tablet, extended release; injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.