Application 050819
- Type
- NDA
- Sponsor
- BAUSCH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACANYA | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | GEL;TOPICAL | 2.5%;EQ 1.2% BASE | Yes | Yes |
| 002 | ONEXTON | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | GEL;TOPICAL | 3.75%;EQ 1.2% BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050819-001 | ACANYA | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 |
| N050819-002 | ONEXTON | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N050819-001 | AB |
| N050819-002 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N050819-001 | 10220049 | 2029-06-03 | U-916 | Drug product | 2019-03-08 |
| N050819-001 | 10624918 | 2029-06-03 | U-916 | 2020-05-11 | |
| N050819-001 | 8663699 | 2029-06-03 | U-124 | 2014-03-06 | |
| N050819-001 | 8895070 | 2029-06-03 | U-124 | 2015-05-19 | |
| N050819-001 | 9078870 | 2029-06-03 | Drug product | 2015-10-13 | |
| N050819-001 | 8288434 | 2029-08-05 | U-124 | Drug product | 2012-10-19 |
| N050819-002 | 10137142 | 2029-06-03 | U-916 | Drug product | 2018-11-28 |
| N050819-002 | 10220049 | 2029-06-03 | U-916 | Drug product | 2019-03-08 |
| N050819-002 | 9504704 | 2029-06-03 | U-124 | Drug product | 2016-12-01 |
| N050819-002 | 9504704 | 2029-06-03 | U-134 | Drug product | 2016-12-01 |
| N050819-002 | 9504704 | 2029-06-03 | U-818 | Drug product | 2016-12-01 |
| N050819-002 | 9504704 | 2029-06-03 | U-916 | Drug product | 2016-12-01 |
| N050819-002 | 9561208 | 2029-06-03 | U-916 | Drug product | 2017-02-08 |
| N050819-002 | 8288434 | 2029-08-05 | U-1033 | Drug product | 2014-12-03 |
| N050819-002 | 8288434 | 2029-08-05 | U-124 | Drug product | 2014-12-03 |
| N050819-002 | 8288434 | 2029-08-05 | U-134 | Drug product | 2014-12-03 |
| N050819-002 | 8288434 | 2029-08-05 | U-818 | Drug product | 2014-12-03 |
| N050819-002 | 8288434 | 2029-08-05 | U-916 | Drug product | 2014-12-03 |
| N050819-002 | 8288434 | 2029-08-05 | U-921 | Drug product | 2014-12-03 |
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 | 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 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2014-11-24 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | RLD, RS | 2014-11-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | RLD, RS | 2014-11-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | RLD, RS | 2014-11-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050819-001 | ACANYA | 2.5%;EQ 1.2% BASE | GEL / TOPICAL | AB | RLD, RS | 2008-10-23 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050819-002 | ONEXTON | 3.75%;EQ 1.2% BASE | GEL / TOPICAL | RLD, RS | 2014-11-24 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N050819-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N050819-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050819-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050819-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050819-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050819-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050819-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050819-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050819-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050819-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050819-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050819-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050819-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050819-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050819-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050819-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050819-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050819-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050819-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050819-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N050819-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050819-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050819-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050819-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050819-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050819-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050819-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050819-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050819-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050819-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050819-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050819-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050819-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050819-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050819-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050819-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N050819-001 | AB | 1 | 5aa47cf7b7d7… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N050819-001 | 10220049 | 2029-06-03 | U-916 | Drug product | 2019-03-08 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-001 | 10624918 | 2029-06-03 | U-916 | 2020-05-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050819-001 | 8663699 | 2029-06-03 | U-124 | 2014-03-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050819-001 | 8895070 | 2029-06-03 | U-124 | 2015-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050819-001 | 9078870 | 2029-06-03 | Drug product | 2015-10-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050819-001 | 8288434 | 2029-08-05 | U-124 | Drug product | 2012-10-19 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-002 | 10137142 | 2029-06-03 | U-916 | Drug product | 2018-11-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-002 | 10220049 | 2029-06-03 | U-916 | Drug product | 2019-03-08 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-002 | 9504704 | 2029-06-03 | U-134 | Drug product | 2016-12-01 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-002 | 9504704 | 2029-06-03 | U-818 | Drug product | 2016-12-01 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-002 | 9504704 | 2029-06-03 | U-916 | Drug product | 2016-12-01 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-002 | 9504704 | 2029-06-03 | U-124 | Drug product | 2016-12-01 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-002 | 9561208 | 2029-06-03 | U-916 | Drug product | 2017-02-08 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-002 | 8288434 | 2029-08-05 | U-818 | Drug product | 2014-12-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-002 | 8288434 | 2029-08-05 | U-124 | Drug product | 2014-12-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-002 | 8288434 | 2029-08-05 | U-134 | Drug product | 2014-12-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-002 | 8288434 | 2029-08-05 | U-1033 | Drug product | 2014-12-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-002 | 8288434 | 2029-08-05 | U-921 | Drug product | 2014-12-03 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N050819-002 | 8288434 | 2029-08-05 | U-916 | Drug product | 2014-12-03 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-001 | 10220049 | 2029-06-03 | U-916 | Drug product | 2019-03-08 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-001 | 10624918 | 2029-06-03 | U-916 | 2020-05-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050819-001 | 8663699 | 2029-06-03 | U-124 | 2014-03-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050819-001 | 8895070 | 2029-06-03 | U-124 | 2015-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050819-001 | 9078870 | 2029-06-03 | Drug product | 2015-10-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050819-001 | 8288434 | 2029-08-05 | U-124 | Drug product | 2012-10-19 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-002 | 10137142 | 2029-06-03 | U-916 | Drug product | 2018-11-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-002 | 10220049 | 2029-06-03 | U-916 | Drug product | 2019-03-08 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-002 | 9504704 | 2029-06-03 | U-134 | Drug product | 2016-12-01 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-002 | 9504704 | 2029-06-03 | U-818 | Drug product | 2016-12-01 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-002 | 9504704 | 2029-06-03 | U-916 | Drug product | 2016-12-01 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-002 | 9504704 | 2029-06-03 | U-124 | Drug product | 2016-12-01 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-002 | 9561208 | 2029-06-03 | U-916 | Drug product | 2017-02-08 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-002 | 8288434 | 2029-08-05 | U-818 | Drug product | 2014-12-03 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-002 | 8288434 | 2029-08-05 | U-124 | Drug product | 2014-12-03 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-002 | 8288434 | 2029-08-05 | U-134 | Drug product | 2014-12-03 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-002 | 8288434 | 2029-08-05 | U-1033 | Drug product | 2014-12-03 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-002 | 8288434 | 2029-08-05 | U-921 | Drug product | 2014-12-03 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N050819-002 | 8288434 | 2029-08-05 | U-916 | Drug product | 2014-12-03 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N050819-001 | 10220049 | 2029-06-03 | U-916 | Drug product | 2019-03-08 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050819-001 | 10624918 | 2029-06-03 | U-916 | 2020-05-11 | 011fe1cb6892… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Clindamycin Phosphate and Benzoyl Peroxide | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | Oceanside Pharmaceuticals | 1d53ec2b-d33d-4245-99f1-e41b30303660 | 2025-08-15 | Warnings, Adverse reactions | 050819 NDA050819 |
| ONEXTON | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | Bausch Health US, LLC | 697e760a-c206-4565-8f4e-a8085e215827 | 2025-07-23 | Warnings, Adverse reactions | 050819 NDA050819 0187-3050 |
| Acanya | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | Bausch Health US, LLC | 3dcd2c96-72b1-4a9f-b65c-08198d63b7df | 2020-09-30 | Warnings, Adverse reactions | 050819 NDA050819 13548-132 |
| Clindamycin Phosphate and Benzoyl Peroxide | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | Oceanside Pharmaceuticals | edae294f-cc8b-4f94-8d90-4c764fda307b | 2020-09-30 | Warnings, Adverse reactions | 050819 NDA050819 68682-132 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0187-3050 | ONEXTON | Clindamycin Phosphate and Benzoyl Peroxide | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 0187-3050 | ONEXTON | Clindamycin Phosphate and Benzoyl Peroxide | Bausch Health US, LLC | NDA | Current |
| 0187-3050 | ONEXTON | Clindamycin Phosphate and Benzoyl Peroxide | Bausch Health US, LLC | NDA | Current |
| 13548-132 | Acanya | Clindamycin Phosphate and Benzoyl Peroxide | Bausch Health US, LLC | NDA | Current |
| 13548-132 | Acanya | Clindamycin Phosphate and Benzoyl Peroxide | Bausch Health US, LLC | NDA | Current |
| 13548-132 | Acanya | Clindamycin Phosphate and Benzoyl Peroxide | Bausch Health US, LLC | NDA | Current |
| 13548-132 | ACANYA | Clindamycin Phosphate and Benzoyl Peroxide | Valent Pharmaceuticals North America | NDA | Current |
| 68682-132 | Clindamycin Phosphate and Benzoyl Peroxide | Clindamycin Phosphate and Benzoyl Peroxide | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-132 | Clindamycin Phosphate and Benzoyl Peroxide | Clindamycin Phosphate and Benzoyl Peroxide | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-132 | Clindamycin Phosphate and Benzoyl Peroxide | Clindamycin Phosphate and Benzoyl Peroxide | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68682-132 | Clindamycin Phosphate and Benzoyl Peroxide | Clindamycin Phosphate and Benzoyl Peroxide | Oceanside Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61978 | SUPPL | 2020-02-27 |
| 61977 | SUPPL | 2020-02-27 |
| 61953 | SUPPL | 2020-02-25 |
| 61952 | SUPPL | 2020-02-25 |
| 58715 | SUPPL | 2019-05-15 |
| 39388 | SUPPL | 2014-11-26 |
| 30613 | SUPPL | 2014-11-26 |
| 30612 | SUPPL | 2014-03-05 |
| 39387 | SUPPL | 2014-03-04 |
| 30611 | SUPPL | 2010-10-20 |
| 18299 | SUPPL | 2010-10-18 |
| 18298 | SUPPL | 2010-07-01 |
| 30610 | SUPPL | 2010-06-29 |
| 42754 | ORIG | 2009-10-29 |
| 24349 | ORIG | 2009-10-29 |
| 39386 | ORIG | 2008-11-07 |
| 30609 | ORIG | 2008-10-29 |
| 63512 | ORIG | 1900-01-01 |
| 63511 | ORIG | 1900-01-01 |
| 63510 | ORIG | 1900-01-01 |