VIZIMPRO — FDA application NDA211288

Application NDA211288 · type NDA · FDA status: approved · original approval 2018-09-27

Listed sponsor: PFIZER · PFE 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	VIZIMPRO	DACOMITINIB	TABLET	ORAL	15MG	Discontinued	not listed	Yes
002	VIZIMPRO	DACOMITINIB	TABLET	ORAL	30MG	Discontinued	not listed	Yes
003	VIZIMPRO	DACOMITINIB	TABLET	ORAL	45MG	Discontinued	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 10596162	001	listed patent expiry date: 2026-02-02	U-3338
Patent 10596162	002	listed patent expiry date: 2026-02-02	U-3338
Patent 10596162	003	listed patent expiry date: 2026-02-02	U-3338
Patent 10603314	001	listed patent expiry date: 2026-02-02	U-3337
Patent 10603314	002	listed patent expiry date: 2026-02-02	U-3337
Patent 10603314	003	listed patent expiry date: 2026-02-02	U-3337
Patent 7772243	001	listed patent expiry date: 2032-09-27	drug substance, drug product
Patent 7772243	002	listed patent expiry date: 2032-09-27	drug substance, drug product
Patent 7772243	003	listed patent expiry date: 2032-09-27	drug substance, drug product

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

DACOMITINIB · UNII 5092U85G58 · lmmol compound BSPLGGCPNTZPIH-IPZCTEOASA-N · CHEMBL2105719

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.