Application 213628

Type: ANDA
Sponsor: ORANGE

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	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
A213628-001	ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28
A213628-002	ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213628-001	AB
A213628-002	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 2 · 66 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
2026-02-19 14:30 UTC	2026-02	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB		2021-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB		2021-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB		2021-06-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB		2021-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB		2021-06-28	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213628-001	ERYTHROMYCIN	250MG	TABLET / ORAL	AB		2021-06-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213628-002	ERYTHROMYCIN	500MG	TABLET / ORAL	AB	RS	2021-06-28	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 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	A213628-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213628-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213628-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213628-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213628-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213628-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213628-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213628-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213628-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213628-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213628-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213628-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213628-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213628-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213628-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213628-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213628-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213628-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213628-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213628-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213628-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213628-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213628-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213628-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213628-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213628-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213628-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213628-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213628-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213628-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213628-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213628-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213628-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213628-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213628-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213628-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213628-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213628-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213628-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213628-002	AB	1	`6a51e52b5d6a…`

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
ERYTHROMYCIN	ERYTHROMYCIN	Nivagen Pharmaceuticals, Inc.	aa61cb37-5fc5-4225-b894-1d660386777f	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213628 application number: ANDA213628 ndc (product): 75834-243 ndc (product): 75834-242
Erythromycin	ERYTHROMYCIN	Modavar Pharmaceuticals LLC	bc3d091b-1fc8-4f7a-a3c2-8ede87f5faa0	2023-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213628 application number: ANDA213628 ndc (product): 72241-036 ndc (product): 72241-037
Erythromycin	ERYTHROMYCIN	Cadila Pharmaceuticals Limited	fae8fc38-3c60-43b8-a0f9-2c50df332505	2023-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213628 application number: ANDA213628 ndc (product): 71209-101 ndc (product): 71209-100
Erythromycin	ERYTHROMYCIN	Orange Pharmaceuticals USA LLC	379ed8f7-b54f-495f-932e-cd0e4c691134	2021-07-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213628 application number: ANDA213628 ndc (product): 73082-010 ndc (product): 73082-020

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71209-100	Erythromycin	Erythromycin	Cadila Pharmaceuticals Limited	ANDA	Current
71209-100	Erythromycin	Erythromycin	Cadila Pharmaceuticals Limited	ANDA	Current
71209-101	Erythromycin	Erythromycin	Cadila Pharmaceuticals Limited	ANDA	Current
71209-101	Erythromycin	Erythromycin	Cadila Pharmaceuticals Limited	ANDA	Current
72241-036	Erythromycin	Erythromycin	Modavar Pharmaceuticals LLC	ANDA	Current
72241-037	Erythromycin	Erythromycin	Modavar Pharmaceuticals LLC	ANDA	Current
73082-010	Erythromycin	Erythromycin	Orange Pharmaceuticals USA LLC	ANDA	Current
73082-020	Erythromycin	Erythromycin	Orange Pharmaceuticals USA LLC	ANDA	Current
75834-242	Erythromycin	Erythromycin	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-243	Erythromycin	Erythromycin	Nivagen Pharmaceuticals, Inc.	ANDA	Current