Application 061621

Type: ANDA
Sponsor: ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERYTHROMYCIN	ERYTHROMYCIN	TABLET;ORAL	250MG	No	No
002	ERYTHROMYCIN	ERYTHROMYCIN	TABLET;ORAL	500MG	No	Yes

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
A061621-001	ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982
A061621-002	ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A061621-001	AB
A061621-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A061621-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A061621-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS, Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A061621-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061621-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061621-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061621-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061621-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061621-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061621-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061621-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061621-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061621-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061621-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061621-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061621-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061621-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061621-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061621-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061621-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061621-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061621-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061621-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061621-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061621-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061621-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061621-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061621-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061621-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061621-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A061621-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061621-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061621-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061621-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A061621-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061621-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A061621-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A061621-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A061621-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061621-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A061621-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A061621-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A061621-002	AB	1	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Erythromycin	ERYTHROMYCIN	PD-Rx Pharmaceuticals, Inc.	e54d66fa-93bb-4339-a75e-194a2e4488aa	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061621 application number: ANDA061621 ndc (product): 55289-075
Erythromycin	ERYTHROMYCIN	Wilshire Pharmaceuticals	f2efbc94-64f7-4130-ab23-e5983854f730	2019-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061621 application number: ANDA061621 ndc (product): 52536-103 ndc (product): 52536-105
Erythromycin	ERYTHROMYCIN	Arbor Pharmaceuticals, Inc.	ca1326d6-c5c6-4572-96b6-e56cd944799c	2018-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061621 application number: ANDA061621 ndc (product): 24338-102 ndc (product): 24338-104

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-387	ERYTHROMYCIN Base Filmtab	ERYTHROMYCIN	Rebel Distributors Corp	ANDA	Current
21695-389	ERYTHROMYCIN Base Filmtab	ERYTHROMYCIN	Rebel Distributors Corp	ANDA	Current
21695-457	ERY-TAB	erythromycin	Rebel Distributors Corp	ANDA	Current
24338-102	Erythromycin	Erythromycin	Arbor Pharmaceuticals, Inc.	ANDA	Current
24338-104	Erythromycin	Erythromycin	Arbor Pharmaceuticals, Inc.	ANDA	Current
50090-0361	Erythromycin	Erythromycin	A-S Medication Solutions	ANDA	Current
50090-0361	Erythromycin	Erythromycin	A-S Medication Solutions	ANDA	Current
52536-103	Erythromycin	Erythromycin	Wilshire Pharmaceuticals	ANDA	Current
52536-105	Erythromycin	Erythromycin	Wilshire Pharmaceuticals	ANDA	Current
55289-025	Erythromycin	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-025	Erythromycin	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-025	Erythromycin	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-025	Erythromycin	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-075	Erythromycin	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-075	Erythromycin	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-075	Erythromycin	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-075	Erythromycin	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
68151-1176	Erythromycin	Erythromycin	Carilion Materials Management	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60855	SUPPL	2019-11-15
60835	SUPPL	2019-11-14
22254	ORIG	2016-07-28
39394	SUPPL	2014-01-31