# XACIATO — FDA application NDA215650

Informational only - not investment advice.

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

Listed sponsor: ORGANON LLC · [OGN company profile](/company/OGN/) · 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 |

## Orange Book patent and exclusivity listings

- Patent 11129896, product 001; listed patent expiry date: 2036-09-22.
- Patent 12303563, product 001; listed patent expiry date: 2036-09-22.
- Exclusivity NP, product 001; listed exclusivity date: 2024-12-07.
- Exclusivity GAIN, product 001; listed exclusivity date: 2029-12-07.

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

## Compound cross-links

- CLINDAMYCIN PHOSPHATE · UNII EH6D7113I8 · [lmmol compound UFUVLHLTWXBHGZ-MGZQPHGTSA-N](https://lmmol.com/compound/UFUVLHLTWXBHGZ-MGZQPHGTSA-N)

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

## Related pages

- [Sponsor company](/company/OGN/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA215650. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.