Application 210954

Type: ANDA
Sponsor: AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERYTHROMYCIN	ERYTHROMYCIN	TABLET, DELAYED RELEASE;ORAL	250MG	No	No
002	ERYTHROMYCIN	ERYTHROMYCIN	TABLET, DELAYED RELEASE;ORAL	333MG	No	No
003	ERYTHROMYCIN	ERYTHROMYCIN	TABLET, DELAYED RELEASE;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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A210954-001	ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02
A210954-002	ERYTHROMYCIN	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02
A210954-003	ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210954-001	AB
A210954-002	AB
A210954-003	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 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210954-002	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210954-003	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210954-001	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-02	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A210954-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210954-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210954-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210954-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210954-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210954-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210954-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210954-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210954-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210954-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210954-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210954-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210954-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210954-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210954-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210954-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210954-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210954-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210954-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210954-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210954-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210954-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210954-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210954-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210954-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210954-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210954-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210954-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210954-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210954-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210954-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210954-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210954-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210954-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210954-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210954-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210954-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210954-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210954-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210954-001	AB	1	`8072bd15b7f6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Erythromycin	ERYTHROMYCIN	Amneal Pharmaceuticals NY LLC	bb641ed4-8093-4e15-9cb9-8921b1093d50	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210954 application number: ANDA210954 ndc (product): 69238-1473 ndc (product): 69238-1472 ndc (product): 69238-1471

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4616	Erythromycin	Erythromycin	A-S Medication Solutions	ANDA	Current
69238-1471	Erythromycin	Erythromycin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1471	Erythromycin	Erythromycin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1471	Erythromycin	Erythromycin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1471	Erythromycin	Erythromycin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1471	Erythromycin	Erythromycin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1472	Erythromycin	Erythromycin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1472	Erythromycin	Erythromycin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1472	Erythromycin	Erythromycin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1472	Erythromycin	Erythromycin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1472	Erythromycin	Erythromycin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1473	Erythromycin	Erythromycin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1473	Erythromycin	Erythromycin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1473	Erythromycin	Erythromycin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1473	Erythromycin	Erythromycin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1473	Erythromycin	Erythromycin	Amneal Pharmaceuticals NY LLC	ANDA	Current