Application 203688

Type: ANDA
Sponsor: TOLMAR

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
A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;1.2%	GEL / TOPICAL			2016-08-25

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.

Product history page 1 of 2 · 41 observed 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	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2016-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2016-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2016-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2016-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2016-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2016-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2016-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	2016-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203688-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL		2016-08-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A203688-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203688-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203688-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203688-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203688-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203688-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203688-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203688-001	AB	1	`ea99ee380514…`

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN AND BENZOYL PEROXIDE GEL	Sun Pharmaceutical Industries, Inc.	6df9e011-3959-411d-9e28-1df097829028	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Encube Ethicals, Inc.	977b2395-14ff-4c64-9a1e-77ef75805a83	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Oceanside Pharmaceuticals	1d53ec2b-d33d-4245-99f1-e41b30303660	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN AND BENZOYL PEROXIDE GEL	Sun Pharmaceutical Industries, Inc.	bde03712-b9c7-4953-af2e-d3270ba1a917	2025-07-07	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN AND BENZOYL PEROXIDE GEL	Sun Pharmaceutical Industries, Inc.	10e10bc2-4074-4268-916b-dd2f40fb7bb3	2025-07-07	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN AND BENZOYL PEROXIDE GEL	Sun Pharmaceutical Industries, Inc.	3b151c49-d44c-4a24-b7ff-329797a2cda3	2025-07-07	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Sun Pharmaceutical Industries, Inc.	b39aaacb-f429-4cb4-b88b-341b8b8b217c	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Sun Pharmaceutical Industries, Inc.	0a98fc1e-be75-4c22-a7a7-2e4f033b3701	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Sun Pharmaceutical Industries, Inc.	449884c1-cf3b-4e2c-b8a0-82442ea8523a	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Mayne Pharma	c7381600-2e4c-4e7b-aa67-fe7d5fae7b40	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Zydus Lifesciences Limited	cc45f9bc-4639-4d95-b12d-01f6504592bb	2024-11-26		Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Bryant Ranch Prepack	db39492e-d964-4e59-8d65-0a2194e9a3d4	2024-11-11	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE, BENZOYL PEROXIDE	Bryant Ranch Prepack	4e09c0e6-7da1-462c-9f1f-64c18e5f58f9	2024-10-18	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Mylan Pharmaceuticals Inc.	96b3e35a-e174-49cd-8695-acd7d23e7710	2024-10-15	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Mylan Pharmaceuticals Inc.	0e98ee9b-84e9-4cd8-a3ea-1247e1a510a5	2024-10-15	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Padagis Israel Pharmaceuticals Ltd	2dfc025a-8eac-4e05-a1fe-dc22914002bb	2023-12-31	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
clindamycin phosphate and benzoyl peroxide	CLINDAMYCIN, BENZOYL PEROXIDE	Padagis Israel Pharmaceuticals Ltd	1c7040f2-e503-408a-b07e-72c7972ce78d	2023-07-26	Warnings, Adverse reactions	Name fallback brand name: clindamycin phosphate and benzoyl peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE, BENZOYL PEROXIDE	Bryant Ranch Prepack	ac7f5c47-a06a-495f-a914-13c930106c8d	2023-07-17	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Zydus Pharmaceuticals USA Inc.	83d52507-99a1-4461-b067-5ec01dc6c5d3	2022-10-05	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE, BENZOYL PEROXIDE	Padagis Israel Pharmaceuticals Ltd	221de6a3-c1d7-4dcf-a47b-51edaa682c2a	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate and Benzoyl Peroxide

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-7161	Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin Phosphate and Benzoyl Peroxide	Sandoz Inc.	ANDA	Current
0781-7161	Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin Phosphate and Benzoyl Peroxide	Sandoz Inc.	ANDA	Current
63629-8798	Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin Phosphate and Benzoyl Peroxide	Bryant Ranch Prepack	ANDA	Current
63629-8798	Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin Phosphate and Benzoyl Peroxide	Bryant Ranch Prepack	ANDA	Current