Application 050207

Type: NDA
Sponsor: ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	E.E.S.	ERYTHROMYCIN ETHYLSUCCINATE	GRANULE;ORAL	EQ 200MG BASE/5ML	Yes	No
002	ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	GRANULE;ORAL	EQ 400MG BASE/5ML	Yes	Yes
003	ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	GRANULE;ORAL	EQ 200MG BASE/5ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050207-001	E.E.S.	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982
N050207-002	ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982
N050207-003	ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N050207-001	AB
N050207-002	AB
N050207-003	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 4 of 4 · 132 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
2022-10-28 04:53 UTC	2022-10	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050207-001	E.E.S.	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD, Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050207-002	ERYPED	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	RLD, RS, Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050207-003	ERYPED	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	RLD	1987-03-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N050207-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050207-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050207-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050207-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050207-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050207-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050207-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050207-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050207-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050207-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050207-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050207-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050207-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050207-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050207-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050207-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050207-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050207-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050207-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050207-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050207-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050207-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050207-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050207-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050207-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050207-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050207-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050207-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050207-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050207-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050207-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050207-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050207-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050207-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050207-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050207-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050207-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050207-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050207-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050207-001	AB	1	`79d66fd596c7…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
E.E.S 400	ERYTHROMYCIN ETHYLSUCCINATE	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	b455bbdb-a3f1-470f-aa5f-ed83ac2e228d	2023-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050207 application number: NDA050207 ndc (product): 24338-136 ndc (product): 24338-134
Ery-Ped	ERYTHROMYCIN ETHYLSUCCINATE	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	04775721-ab87-4b66-808c-d67a21032385	2023-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050207 application number: NDA050207 ndc (product): 24338-130 ndc (product): 24338-132
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	Wilshire Pharmaceuticals	86d6353c-2b58-4219-b31d-fb5b97789094	2020-09-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050207 application number: NDA050207 ndc (product): 52536-132 ndc (product): 52536-130
Erythromycin Ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Wilshire Pharmaceuticals Inc.	f4a3fffd-ce02-450f-bbcc-d425374e3e32	2019-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050207 application number: NDA050207 ndc (product): 52536-136 ndc (product): 52536-134

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 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24338-130	Ery-Ped	Erythromycin Ethylsuccinate	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	NDA	Current
24338-130	Ery-Ped	Erythromycin Ethylsuccinate	Arbor Pharmaceuticals, Inc.	NDA	Current
24338-130	Ery-Ped	Erythromycin Ethylsuccinate	Arbor Pharmaceuticals, Inc.	NDA	Current
24338-132	Ery-Ped	Erythromycin Ethylsuccinate	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	NDA	Current
24338-132	Ery-Ped	Erythromycin Ethylsuccinate	Arbor Pharmaceuticals, Inc.	NDA	Current
24338-132	Ery-Ped	Erythromycin Ethylsuccinate	Arbor Pharmaceuticals, Inc.	NDA	Current
24338-134	E.E.S	Erythromycin Ethylsuccinate	Arbor Pharmaceuticals, Inc.	NDA	Current
24338-134	E.E.S	Erythromycin Ethylsuccinate	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	NDA	Current
24338-134	E.E.S	Erythromycin Ethylsuccinate	Arbor Pharmaceuticals, Inc.	NDA	Current
24338-134	E.E.S	Erythromycin Ethylsuccinate	Arbor Pharmaceuticals, Inc.	NDA	Current
24338-134	E.E.S	Erythromycin Ethylsuccinate	Arbor Pharmaceuticals, Inc.	NDA	Current
24338-136	E.E.S	Erythromycin Ethylsuccinate	Arbor Pharmaceuticals, Inc.	NDA	Current
24338-136	E.E.S	Erythromycin Ethylsuccinate	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	NDA	Current
24338-136	E.E.S	Erythromycin Ethylsuccinate	Arbor Pharmaceuticals, Inc.	NDA	Current
24338-136	E.E.S	Erythromycin Ethylsuccinate	Arbor Pharmaceuticals, Inc.	NDA	Current
24338-136	E.E.S	Erythromycin Ethylsuccinate	Arbor Pharmaceuticals, Inc.	NDA	Current
52536-130	ERYTHROMYCIN ETHYLSUCCINATE	Erythromycin Ethylsuccinate	Wilshire Pharmaceuticals	NDA	Current
52536-130	ERYTHROMYCIN ETHYLSUCCINATE	Erythromycin Ethylsuccinate	Wilshire Pharmaceuticals	NDA	Current
52536-132	ERYTHROMYCIN ETHYLSUCCINATE	Erythromycin Ethylsuccinate	Wilshire Pharmaceuticals	NDA	Current
52536-134	Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	Wilshire Pharmaceuticals Inc.	NDA	Current
52536-136	Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	Wilshire Pharmaceuticals Inc.	NDA	Current
63629-2500	Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	Bryant Ranch Prepack	NDA	Current
63629-2500	Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53809	SUPPL	2018-04-24
53802	SUPPL	2018-04-24
49497	SUPPL	2017-08-22
49494	SUPPL	2017-08-21
17812	SUPPL	2012-02-06
7717	SUPPL	2012-02-06
7714	SUPPL	2011-02-07
17810	SUPPL	2011-01-31
29996	SUPPL	2010-11-08
17811	SUPPL	2009-01-02
7716	SUPPL	2008-12-19
7715	SUPPL	2008-05-28
29995	SUPPL	2008-01-09
38923	SUPPL	2008-01-08
7712	SUPPL	2006-08-14
17809	SUPPL	2006-08-11
42639	SUPPL	2004-09-21
22154	SUPPL	2004-09-21
7713	SUPPL	2004-03-16
7711	SUPPL	2002-04-25