Application 050297

Type: NDA
Sponsor: ARBOR PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	E.E.S.	ERYTHROMYCIN ETHYLSUCCINATE	TABLET, CHEWABLE;ORAL	EQ 200MG BASE	No	No
003	ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	TABLET, CHEWABLE;ORAL	EQ 200MG 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050297-002	E.E.S.	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		Approved before 1982
N050297-003	ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE	TABLET, CHEWABLE / ORAL			1988-07-05

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050297-002	E.E.S.	EQ 200MG BASE	TABLET, CHEWABLE / ORAL	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050297-003	ERYPED	EQ 200MG BASE	TABLET, CHEWABLE / ORAL		1988-07-05	`782e0a99824c…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
E.E.S 400	ERYTHROMYCIN ETHYLSUCCINATE	REMEDYREPACK INC.	49b3ca93-43cc-439c-8f5d-e3ea2e87ad2f	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Bryant Ranch Prepack	78139f33-0965-4bbb-a53f-6d7fd4fa9a81	2026-06-05	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Bryant Ranch Prepack	1d9eb7cb-0b11-4f6e-8a9c-1bcff37fe0b5	2026-06-05	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Kanchan Healthcare Inc	a7f7faaf-dc05-4d51-86c6-bf5d61562e48	2026-04-08	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin Ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	ANI Pharmaceuticals, Inc.	3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f	2025-06-20	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin Ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	ANI Pharmaceuticals, Inc.	3de1e0b9-473b-44c0-a644-5fa14ad69a83	2025-06-20	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin Ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Nivagen Pharmaceuticals, Inc.	46f74c4f-10fc-44cf-aec4-d113f49149bc	2024-01-02	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE
E.E.S 400	ERYTHROMYCIN ETHYLSUCCINATE	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	b455bbdb-a3f1-470f-aa5f-ed83ac2e228d	2023-12-16	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE
Ery-Ped	ERYTHROMYCIN ETHYLSUCCINATE	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	04775721-ab87-4b66-808c-d67a21032385	2023-12-16	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	23a0564e-dca9-41bc-b2c7-0461169f65f9	2023-12-16	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Cadila Pharmaceuticals Limited	db70798e-5e07-41d6-afe9-82c272bc5cc0	2023-11-11	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	Wilshire Pharmaceuticals	86d6353c-2b58-4219-b31d-fb5b97789094	2020-09-24	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin Ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Wilshire Pharmaceuticals Inc.	f4a3fffd-ce02-450f-bbcc-d425374e3e32	2019-01-29	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30003	SUPPL	2012-08-17
38925	SUPPL	2012-08-16
7725	SUPPL	2010-11-08
17817	SUPPL	2009-01-02
30002	SUPPL	2008-12-19
30001	SUPPL	2008-05-28
30000	SUPPL	2008-01-09
38924	SUPPL	2008-01-08
29999	SUPPL	2006-08-14
17816	SUPPL	2006-08-11
42640	SUPPL	2004-09-21
7724	SUPPL	2004-03-16
7723	SUPPL	2002-04-25