Application 216632

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CABTREO	ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	GEL;TOPICAL	0.15%;3.1%;1.2%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N216632-001	CABTREO	ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	0.15%;3.1%;1.2%	GEL / TOPICAL		RLD, RS	2023-10-20

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216632-001	10220049	2029-06-03	U-3713	Drug product	2023-11-02
N216632-001	10624918	2029-06-03	U-3713		2023-11-02
N216632-001	9561208	2029-06-03	U-3713	Drug product	2023-11-02
N216632-001	8288434	2029-08-05	U-3713	Drug product	2023-11-02
N216632-001	12128059	2040-07-31	U-3713	Drug product	2024-11-08
N216632-001	12133859	2040-07-31		Drug product	2024-11-22
N216632-001	12138278	2040-07-31		Drug product	2024-12-06
N216632-001	12616710	2040-07-31		Drug product	2026-05-21
N216632-001	11389467	2040-12-28	U-3713	Drug product	2023-11-02

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216632-001	NP	2026-10-20

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216632-001	CABTREO	0.15%;3.1%;1.2%	GEL / TOPICAL	RLD, RS	2023-10-20	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216632-001	10220049	2029-06-03	U-3713	Drug product	2023-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216632-001	10624918	2029-06-03	U-3713		2023-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216632-001	9561208	2029-06-03	U-3713	Drug product	2023-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216632-001	8288434	2029-08-05	U-3713	Drug product	2023-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216632-001	12128059	2040-07-31	U-3713	Drug product	2024-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216632-001	12133859	2040-07-31		Drug product	2024-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216632-001	12138278	2040-07-31		Drug product	2024-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216632-001	12616710	2040-07-31		Drug product	2026-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216632-001	11389467	2040-12-28	U-3713	Drug product	2023-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216632-001	10220049	2029-06-03	U-3713	Drug product	2023-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216632-001	10624918	2029-06-03	U-3713		2023-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216632-001	9561208	2029-06-03	U-3713	Drug product	2023-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216632-001	8288434	2029-08-05	U-3713	Drug product	2023-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216632-001	12128059	2040-07-31	U-3713	Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216632-001	12133859	2040-07-31		Drug product	2024-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216632-001	12138278	2040-07-31		Drug product	2024-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216632-001	11389467	2040-12-28	U-3713	Drug product	2023-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216632-001	10220049	2029-06-03	U-3713	Drug product	2023-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216632-001	10624918	2029-06-03	U-3713		2023-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216632-001	9561208	2029-06-03	U-3713	Drug product	2023-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216632-001	8288434	2029-08-05	U-3713	Drug product	2023-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216632-001	12128059	2040-07-31	U-3713	Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216632-001	12133859	2040-07-31		Drug product	2024-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216632-001	12138278	2040-07-31		Drug product	2024-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216632-001	11389467	2040-12-28	U-3713	Drug product	2023-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216632-001	10220049	2029-06-03	U-3713	Drug product	2023-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216632-001	10624918	2029-06-03	U-3713		2023-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216632-001	9561208	2029-06-03	U-3713	Drug product	2023-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216632-001	8288434	2029-08-05	U-3713	Drug product	2023-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216632-001	12128059	2040-07-31	U-3713	Drug product	2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216632-001	12133859	2040-07-31		Drug product	2024-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216632-001	12138278	2040-07-31		Drug product	2024-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216632-001	11389467	2040-12-28	U-3713	Drug product	2023-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216632-001	10220049	2029-06-03	U-3713	Drug product	2023-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216632-001	10624918	2029-06-03	U-3713		2023-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216632-001	9561208	2029-06-03	U-3713	Drug product	2023-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216632-001	8288434	2029-08-05	U-3713	Drug product	2023-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216632-001	12128059	2040-07-31	U-3713	Drug product	2024-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216632-001	12133859	2040-07-31		Drug product	2024-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216632-001	12138278	2040-07-31		Drug product	2024-12-06	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N216632-001	NP	2026-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216632-001	NP	2026-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216632-001	NP	2026-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216632-001	NP	2026-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216632-001	NP	2026-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216632-001	NP	2026-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216632-001	NP	2026-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216632-001	NP	2026-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216632-001	NP	2026-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216632-001	NP	2026-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216632-001	NP	2026-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216632-001	NP	2026-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216632-001	NP	2026-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216632-001	NP	2026-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216632-001	NP	2026-10-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216632-001	NP	2026-10-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216632-001	NP	2026-10-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216632-001	NP	2026-10-20	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216632-001	NP	2026-10-20	`a50c72e98297…`

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
Cabtreo	CLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE/ADAPALENE	Bausch Health US LLC	9468da0f-9978-4c58-8135-0274c3415084	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216632 application number: NDA216632

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77492	ORIG	2024-02-14
75913	ORIG	2023-10-24
75897	ORIG	2023-10-24