Application 061905

Type: ANDA
Sponsor: ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	E.E.S. 400	ERYTHROMYCIN ETHYLSUCCINATE	TABLET;ORAL	EQ 400MG BASE	No	No
002	E.E.S. 400	ERYTHROMYCIN ETHYLSUCCINATE	TABLET;ORAL	EQ 400MG BASE	No	Yes

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

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
A061905-001	E.E.S. 400	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE	TABLET / ORAL		Approved before 1982
A061905-002	E.E.S. 400	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A061905-002	BX

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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A061905-001	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL		Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A061905-002	E.E.S. 400	EQ 400MG BASE	TABLET / ORAL	BX	RS	1982-08-12	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	A061905-002	BX	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A061905-002	BX	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A061905-002	BX	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061905-002	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061905-002	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061905-002	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061905-002	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061905-002	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061905-002	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061905-002	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061905-002	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061905-002	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061905-002	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061905-002	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061905-002	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061905-002	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061905-002	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061905-002	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061905-002	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061905-002	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A061905-002	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061905-002	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A061905-002	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A061905-002	BX	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A061905-002	BX	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A061905-002	BX	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A061905-002	BX	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A061905-002	BX	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A061905-002	BX	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A061905-002	BX	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061905-002	BX	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A061905-002	BX	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A061905-002	BX	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A061905-002	BX	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A061905-002	BX	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A061905-002	BX	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A061905-002	BX	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A061905-002	BX	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A061905-002	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A061905-002	BX	1	`3a93d1ddd44b…`

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
E.E.S 400	ERYTHROMYCIN ETHYLSUCCINATE	REMEDYREPACK INC.	49b3ca93-43cc-439c-8f5d-e3ea2e87ad2f	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061905 application number: ANDA061905
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 (ANDA): 061905 application number: ANDA061905 ndc (product): 24338-100

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
24338-100	E.E.S	Erythromycin Ethylsuccinate	Arbor Pharmaceuticals, Inc.	ANDA	Current
24338-100	E.E.S	Erythromycin Ethylsuccinate	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	ANDA	Current
24338-100	E.E.S	Erythromycin Ethylsuccinate	Arbor Pharmaceuticals, Inc.	ANDA	Current
24338-100	E.E.S	Erythromycin Ethylsuccinate	Arbor Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39396	SUPPL	2014-01-31