Application 065112

Type: ANDA
Sponsor: TOLMAR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERYTHROMYCIN AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; ERYTHROMYCIN	GEL;TOPICAL	5%;3%	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
A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; ERYTHROMYCIN	5%;3%	GEL / TOPICAL			2004-03-29

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	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL	AB	2004-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL	AB	2004-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL	AB	2004-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL	AB	2004-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL	AB	2004-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL	AB	2004-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL	AB	2004-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL	AB	2004-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065112-001	ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	GEL / TOPICAL		2004-03-29	`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	A065112-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065112-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065112-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065112-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065112-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065112-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065112-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065112-001	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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Erythromycin and Benzoyl Peroxide	ERYTHROMYCIN AND BENZOYL PEROXIDE	Rising Pharma Holdings, Inc.	d449d7e2-5c25-406d-87ab-30809d292476	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: Erythromycin and Benzoyl Peroxide
Erythromycin and Benzoyl Peroxide	ERYTHROMYCIN AND BENZOYL PEROXIDE	Oceanside Pharmaceuticals	be5bce27-bbb7-4503-b609-d89a77ee1e05	2019-06-03	Warnings, Adverse reactions	Name fallback brand name: Erythromycin 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
0781-7054	Erythromycin and Benzoyl Peroxide	Erythromycin and Benzoyl Peroxide	Sandoz Inc.	ANDA	Current
0781-7054	Erythromycin and Benzoyl Peroxide	Erythromycin and Benzoyl Peroxide	Sandoz Inc.	ANDA	Current
0781-7094	Erythromycin and Benzoyl Peroxide	Erythromycin and Benzoyl Peroxide	Sandoz Inc.	ANDA	Current
0781-7094	Erythromycin and Benzoyl Peroxide	Erythromycin and Benzoyl Peroxide	Sandoz Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42809	ORIG	2007-07-06