Is Shorla Oncology Inc., FDA approved?

Shorla Oncology Inc., holds no registered establishment of its own; 6 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Shorla Oncology Inc., make?

6 products are listed under Shorla Oncology Inc., in the openFDA NDC Directory, most often as injection; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Shorla Oncology Inc.,

Data as of 28 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 4
Labeller names: 3
Live patents: 1
Countries: 0

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human prescription drug. By marketing category: ANDA 2, NDA 2.

Dosage form	NDCs
injection	2
solution	2

Route	NDCs
intravenous	2
oral	2

Labeller name on the listing	NDCs
shorla oncology inc.	2
shorla oncology inc.	1
shorla oncology inc.,	1

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11957681	IMKELDIimatinib mesylate	product	Apr 2040

Catalogue

Marketed products

Showing 4 of 6.

Brand	Generic name	Form / route	NDC
IMKELDI	imatinib oral	solution, oral	81927-201NDA
JYLAMVO	Methotrexate	solution, oral	81927-204NDA
nelarabine	nelarabine	injection, intravenous	81927-111ANDA
nelarabine	nelarabine	injection, intravenous	81927-375ANDA

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Common questions

Is Shorla Oncology Inc., FDA approved?: Shorla Oncology Inc., holds no registered establishment of its own; 6 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Shorla Oncology Inc., make?: 6 products are listed under Shorla Oncology Inc., in the openFDA NDC Directory, most often as injection; solution. 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.