TEFLARO — FDA application NDA200327

Application NDA200327 · type NDA · FDA status: approved · original approval 2010-10-29

Listed sponsor: ABBVIE · ABBV 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	TEFLARO	CEFTAROLINE FOSAMIL	POWDER	INTRAVENOUS	400MG/VIAL	Prescription	AP	Yes
002	TEFLARO	CEFTAROLINE FOSAMIL	POWDER	INTRAVENOUS	600MG/VIAL	Prescription	AP	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 9629861	001	listed patent expiry date: 2030-09-21	drug product
Patent 9629861	002	listed patent expiry date: 2030-09-21	drug product
Patent 8247400	001	listed patent expiry date: 2031-02-10	drug product, U-282
Patent 8247400	002	listed patent expiry date: 2031-02-10	drug product, U-282

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

CEFTAROLINE FOSAMIL · UNII 7P6FQA5D21 · lmmol compound ZCCUWMICIWSJIX-NQJJCJBVSA-N · CHEMBL501122

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

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.