Home Applications 215650 Application 215650
Type NDA
Sponsor DARE BIOSCIENCE INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XACIATO CLINDAMYCIN PHOSPHATE GEL;VAGINAL 2% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215650-001 XACIATO CLINDAMYCIN PHOSPHATE EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215650-001 11129896 2036-09-22 U-3293 2022-02-03 N215650-001 12303563 2036-09-22 Drug product 2025-06-16
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215650-001 NP 2024-12-07 N215650-001 GAIN 2029-12-07
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215650-001 XACIATO EQ 2% BASE GEL / VAGINAL RLD, RS 2021-12-07 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215650-001 12303563 2036-09-22 Drug product 2025-06-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215650-001 12303563 2036-09-22 Drug product 2025-06-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215650-001 12303563 2036-09-22 Drug product 2025-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215650-001 12303563 2036-09-22 Drug product 2025-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215650-001 12303563 2036-09-22 Drug product 2025-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215650-001 11129896 2036-09-22 U-3293 2022-02-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215650-001 12303563 2036-09-22 Drug product 2025-06-16 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 68 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XACIATO CLINDAMYCIN PHOSPHATE Organon LLC 0423007f-28fa-4159-bf58-9174626d2347 2026-02-19 Warnings, Adverse reactions Exact identifier application applno (NDA): 215650 application number: NDA215650
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 81505-100 XACIATO clindamycin phosphate Dar NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 73695 SUPPL 2023-04-20 73699 SUPPL 2023-03-07 71182 ORIG 2022-06-01 69514 ORIG 2021-12-08 69512 ORIG 2021-12-07