ASTEPRO — FDA application NDA022203

Application NDA022203 · type NDA · FDA status: approved · original approval 2008-10-15

Listed sponsor: VIATRIS · VTRS 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	ASTEPRO	AZELASTINE HYDROCHLORIDE	SPRAY, METERED	NASAL	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Discontinued	not listed	Yes
002	ASTEPRO	AZELASTINE HYDROCHLORIDE	SPRAY, METERED	NASAL	0.2055MG/SPRAY	Discontinued	not listed	No

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 8071073	001	listed patent expiry date: 2028-06-04	drug product
Patent 8071073	002	listed patent expiry date: 2028-06-04	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.

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.