Application 212433

Type: ANDA
Sponsor: ENCUBE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	GEL;TOPICAL	5%;1.2%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;1.2%	GEL / TOPICAL	AB		2021-04-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A212433-001	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212433-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2021-04-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212433-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212433-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212433-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212433-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212433-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212433-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212433-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212433-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212433-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212433-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212433-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212433-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212433-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212433-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212433-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212433-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212433-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212433-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212433-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212433-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212433-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212433-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212433-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212433-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212433-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212433-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212433-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212433-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212433-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212433-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212433-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212433-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212433-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A212433-001	CGT	2023-03-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212433-001	CGT	2023-03-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212433-001	CGT	2023-03-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212433-001	CGT	2023-03-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212433-001	CGT	2023-03-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212433-001	CGT	2023-03-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212433-001	CGT	2023-03-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212433-001	CGT	2023-03-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212433-001	CGT	2023-03-13	`f41ea6bd6efb…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Bryant Ranch Prepack	be216018-c30d-4184-9152-ae238e3edac4	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212433 application number: ANDA212433
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Encube Ethicals, Inc.	8ca01174-431e-449a-a85e-8c68d506776c	2025-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212433 application number: ANDA212433 ndc (product): 21922-022
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Northstar Rx LLC	2fcf4e8d-dd05-49c2-948b-10abbb52e4bc	2024-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212433 application number: ANDA212433
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Bryant Ranch Prepack	abede379-52d1-4000-ae38-cc99f88fe3b2	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212433 application number: ANDA212433

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
21922-022	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Encube Ethicals Private Limited	ANDA	Current