Application 090979

Type: ANDA
Sponsor: PERRIGO ISRAEL

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 43.

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
A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090979-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB		2012-06-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB		2012-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB		2012-06-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB		2012-06-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB		2012-06-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB		2012-06-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090979-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;1.2%	GEL / TOPICAL	AB	RS	2012-06-26	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090979-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090979-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090979-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090979-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090979-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090979-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090979-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090979-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090979-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090979-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090979-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090979-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090979-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090979-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090979-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090979-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090979-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090979-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090979-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090979-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090979-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090979-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090979-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090979-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090979-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090979-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090979-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090979-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090979-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090979-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090979-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090979-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090979-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090979-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090979-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090979-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090979-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090979-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090979-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090979-001	AB	1	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neuac	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Medimetriks Pharmaceuticals	e2cd1c2a-00ee-465e-a4f4-9c0a0bc6266f	2023-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090979 application number: ANDA090979 ndc (product): 43538-176
clindamycin phosphate and benzoyl peroxide	CLINDAMYCIN, BENZOYL PEROXIDE	Padagis Israel Pharmaceuticals Ltd	1c7040f2-e503-408a-b07e-72c7972ce78d	2023-07-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090979 application number: ANDA090979 ndc (product): 45802-736

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
43538-176	Neuac	clindamycin phosphate and benzoyl peroxide	Medimetriks Pharmaceuticals	ANDA	Current
43538-177	Neuac Kit	clindamycin phosphate and benzoyl peroxide	Medimetriks Pharmaceuticals	ANDA	Current
45802-736	clindamycin phosphate and benzoyl peroxide	Clindamycin, Benzoyl Peroxide	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-736	clindamycin phosphate and benzoyl peroxide	Clindamycin, Benzoyl Peroxide	Perrigo New York Inc	ANDA	Current