Application 209252

Type: ANDA
Sponsor: GLENMARK PHARMS

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%;EQ 1% BASE	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
A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209252-001	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.

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	RS	2019-03-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209252-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2019-03-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209252-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209252-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209252-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209252-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209252-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209252-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209252-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209252-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209252-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209252-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209252-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209252-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209252-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209252-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209252-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209252-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209252-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209252-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209252-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209252-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209252-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209252-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209252-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209252-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209252-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209252-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209252-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209252-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209252-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209252-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209252-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209252-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209252-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209252-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209252-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209252-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209252-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209252-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209252-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209252-001	AB	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
clindamycin and benzoyl peroxide	CLINDAMYCIN AND BENZOYL PEROXIDE	NorthStar RxLLC	e19de12c-f29b-42ab-9e81-1af8e4a66643	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209252 application number: ANDA209252 ndc (product): 16714-984
clindamycin and benzoyl peroxide	CLINDAMYCIN AND BENZOYL PEROXIDE	Glenmark Pharmaceuticals Inc., USA	76795d1b-e1f2-4d1d-b42a-f1d4448c63c0	2026-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209252 application number: ANDA209252 ndc (product): 68462-859 ndc (product): 68462-486

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-984	clindamycin and benzoyl peroxide	clindamycin and benzoyl peroxide	NorthStar RxLLC	ANDA	Current
68462-486	clindamycin and benzoyl peroxide	clindamycin and benzoyl peroxide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-486	clindamycin and benzoyl peroxide	clindamycin and benzoyl peroxide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-486	clindamycin and benzoyl peroxide	clindamycin and benzoyl peroxide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-486	clindamycin and benzoyl peroxide	clindamycin and benzoyl peroxide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-859	clindamycin and benzoyl peroxide	clindamycin and benzoyl peroxide	Glenmark Pharmaceuticals Inc., USA	ANDA	Current