Application 062055

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	GRANULE;ORAL	EQ 200MG BASE/5ML	No	No
002	ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	GRANULE;ORAL	EQ 400MG BASE/5ML	No	No
003	ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	GRANULE;ORAL	EQ 200MG BASE/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A062055-001	ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	Approved before 1982
A062055-002	ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02
A062055-003	ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062055-001	AB
A062055-002	AB
A062055-003	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 3 of 4 · 129 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
2019-12-14 00:12 UTC	2019-12	A062055-003	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062055-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB1	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A062055-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A062055-003	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB2		2018-11-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062055-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB1	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A062055-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A062055-003	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB2		2018-11-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062055-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062055-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062055-003	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062055-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A062055-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A062055-003	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062055-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A062055-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A062055-003	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062055-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062055-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062055-003	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062055-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062055-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062055-003	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062055-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062055-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062055-003	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062055-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062055-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062055-003	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062055-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A062055-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A062055-003	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062055-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A062055-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A062055-003	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062055-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062055-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062055-003	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062055-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A062055-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A062055-003	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB		2018-11-02	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A062055-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062055-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062055-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062055-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062055-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062055-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062055-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062055-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062055-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062055-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062055-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062055-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062055-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062055-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062055-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062055-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062055-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062055-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062055-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062055-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062055-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062055-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062055-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062055-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062055-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062055-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062055-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062055-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062055-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062055-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062055-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062055-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062055-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062055-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062055-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062055-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062055-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062055-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062055-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062055-001	AB	1	`301d65b070ca…`

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 Ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	ANI Pharmaceuticals, Inc.	3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f	2025-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062055 application number: ANDA062055 ndc (product): 62559-631 ndc (product): 62559-630
Erythromycin Ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	ANI Pharmaceuticals, Inc.	3de1e0b9-473b-44c0-a644-5fa14ad69a83	2025-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062055 application number: ANDA062055 ndc (product): 62559-440

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
62559-440	Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-440	Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-630	Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-631	Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	ANI Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59047	SUPPL	2019-06-13
59046	SUPPL	2019-06-13