XACIATO — FDA application NDA215650

Application NDA215650 · type NDA · FDA status: approved · original approval 2021-12-07

Listed sponsor: ORGANON LLC · OGN 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	XACIATO	CLINDAMYCIN PHOSPHATE	GEL	VAGINAL	EQ 2% BASE	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 11129896	001	listed patent expiry date: 2036-09-22	U-3293
Patent 12303563	001	listed patent expiry date: 2036-09-22	drug product
Exclusivity NP	001	listed exclusivity date: 2024-12-07	FDA code as listed
Exclusivity GAIN	001	listed exclusivity date: 2029-12-07	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.

CLINDAMYCIN PHOSPHATE · UNII EH6D7113I8 · lmmol compound UFUVLHLTWXBHGZ-MGZQPHGTSA-N · CHEMBL3184512

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.