Application 062298

Type: ANDA
Sponsor: ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERY-TAB	ERYTHROMYCIN	TABLET, DELAYED RELEASE;ORAL	250MG	No	No
002	ERY-TAB	ERYTHROMYCIN	TABLET, DELAYED RELEASE;ORAL	500MG	No	Yes
003	ERY-TAB	ERYTHROMYCIN	TABLET, DELAYED RELEASE;ORAL	333MG	No	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
A062298-001	ERY-TAB	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	Approved before 1982
A062298-002	ERY-TAB	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS, Approved before 1982
A062298-003	ERY-TAB	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB		1982-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062298-001	AB
A062298-002	AB
A062298-003	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	A062298-001	ERY-TAB	250MG	TABLET, DELAYED RELEASE / ORAL	AB	Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A062298-002	ERY-TAB	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS, Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A062298-003	ERY-TAB	333MG	TABLET, DELAYED RELEASE / ORAL	AB		1982-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062298-001	ERY-TAB	250MG	TABLET, DELAYED RELEASE / ORAL	AB	Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A062298-002	ERY-TAB	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS, Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A062298-003	ERY-TAB	333MG	TABLET, DELAYED RELEASE / ORAL	AB		1982-03-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062298-001	ERY-TAB	250MG	TABLET, DELAYED RELEASE / ORAL	AB	Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062298-002	ERY-TAB	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS, Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062298-003	ERY-TAB	333MG	TABLET, DELAYED RELEASE / ORAL	AB		1982-03-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062298-001	ERY-TAB	250MG	TABLET, DELAYED RELEASE / ORAL	AB	Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062298-002	ERY-TAB	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RS, Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062298-003	ERY-TAB	333MG	TABLET, DELAYED RELEASE / ORAL	AB		1982-03-29	`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	A062298-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062298-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062298-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A062298-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062298-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062298-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062298-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062298-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062298-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062298-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062298-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062298-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062298-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062298-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062298-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062298-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062298-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062298-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062298-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062298-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062298-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062298-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062298-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062298-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062298-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062298-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062298-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062298-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062298-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062298-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062298-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062298-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062298-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062298-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062298-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062298-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062298-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062298-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062298-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062298-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Erythromycin	ERYTHROMYCIN	Wilshire Pharmaceuticals	e9b5abbb-2952-44ce-8cbb-415d9be23df4	2024-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062298 application number: ANDA062298 ndc (product): 52536-183 ndc (product): 52536-180 ndc (product): 52536-186
ERY-TAB	ERYTHROMYCIN	Arbor Pharmaceuticals, Inc.	fda44eb6-7901-4b80-ba0b-216f6cacf3fd	2018-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062298 application number: ANDA062298 ndc (product): 24338-126 ndc (product): 24338-124 ndc (product): 24338-122

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 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24338-122	ERY-TAB	Erythromycin	Arbor Pharmaceuticals, Inc.	ANDA	Current
24338-124	ERY-TAB	Erythromycin	Arbor Pharmaceuticals, Inc.	ANDA	Current
24338-126	ERY-TAB	Erythromycin	Arbor Pharmaceuticals, Inc.	ANDA	Current
43063-569	ERY-TAB	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-569	ERY-TAB	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-569	ERY-TAB	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-569	ERY-TAB	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-0339	ERY-TAB	Erythromycin	A-S Medication Solutions	ANDA	Current
50090-0339	ERY-TAB	Erythromycin	A-S Medication Solutions	ANDA	Current
52536-180	Erythromycin	Erythromycin	Wilshire Pharmaceuticals	ANDA	Current
52536-183	Erythromycin	Erythromycin	Wilshire Pharmaceuticals	ANDA	Current
52536-186	Erythromycin	Erythromycin	Wilshire Pharmaceuticals	ANDA	Current
55289-217	ERY-TAB	Erythromycin	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-217	ERY-TAB	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-217	ERY-TAB	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-217	ERY-TAB	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-217	ERY-TAB	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-525	ERY-TAB	Erythromycin	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-525	ERY-TAB	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-525	ERY-TAB	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-525	ERY-TAB	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-525	ERY-TAB	Erythromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
68151-1170	ERY-TAB	Erythromycin	Carilion Materials Management	ANDA	Current
68151-1174	ERY-TAB	Erythromycin	Carilion Materials Management	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39397	SUPPL	2014-01-31