SAVELLA — FDA application NDA022256

Application NDA022256 · type NDA · FDA status: approved · original approval 2009-01-14

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	SAVELLA	MILNACIPRAN HYDROCHLORIDE	TABLET	ORAL	12.5MG	Prescription	AB	Yes
002	SAVELLA	MILNACIPRAN HYDROCHLORIDE	TABLET	ORAL	25MG	Prescription	AB	Yes
003	SAVELLA	MILNACIPRAN HYDROCHLORIDE	TABLET	ORAL	50MG	Prescription	AB	Yes
004	SAVELLA	MILNACIPRAN HYDROCHLORIDE	TABLET	ORAL	100MG	Prescription	AB	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 7994220	001	listed patent expiry date: 2029-09-19	U-819
Patent 7994220	002	listed patent expiry date: 2029-09-19	U-819
Patent 7994220	003	listed patent expiry date: 2029-09-19	U-819
Patent 7994220	004	listed patent expiry date: 2029-09-19	U-819

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.

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.