PEDMARK — FDA application NDA212937

Application NDA212937 · type NDA · FDA status: approved · original approval 2022-09-20

Listed sponsor: FENNEC PHARMS INC · FENC company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
001	PEDMARK	SODIUM THIOSULFATE	SOLUTION	INTRAVENOUS	12.5GM/100ML (125MG/ML)	Prescription	not listed	Yes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Listing	Product	Descriptive date	Flags/code
Patent 10596190	001	listed patent expiry date: 2038-01-05	U-3443
Patent 11291728	001	listed patent expiry date: 2039-07-01	drug product
Patent 11510984	001	listed patent expiry date: 2039-07-01	drug product
Patent 11617793	001	listed patent expiry date: 2039-07-01	drug product
Patent 11964018	001	listed patent expiry date: 2039-07-01	U-3898
Patent 11992530	001	listed patent expiry date: 2039-07-01	U-3948
Patent 11998604	001	listed patent expiry date: 2039-07-01	U-3952
Exclusivity ODE-384	001	listed exclusivity date: 2029-09-20	FDA code as listed

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Peer clusters: No published peer-cluster link for this sponsor.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.