Application 211991

Type: ANDA
Sponsor: PAR PHARM 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

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
A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL			2019-10-23
A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL			2019-10-23

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 · 78 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	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL	AB	2019-10-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL	AB	2019-10-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211991-001	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE / ORAL		2019-10-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211991-002	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE / ORAL		2019-10-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A211991-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211991-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211991-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211991-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211991-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211991-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211991-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211991-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211991-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211991-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211991-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211991-002	AB	1	`3f01610625f2…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A211991-001	CGT	2020-05-09	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211991-002	CGT	2020-05-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211991-001	CGT	2020-05-09	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211991-002	CGT	2020-05-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211991-001	CGT	2020-05-09	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211991-002	CGT	2020-05-09	`3f01610625f2…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
E.E.S 400	ERYTHROMYCIN ETHYLSUCCINATE	REMEDYREPACK INC.	49b3ca93-43cc-439c-8f5d-e3ea2e87ad2f	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Bryant Ranch Prepack	78139f33-0965-4bbb-a53f-6d7fd4fa9a81	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: Erythromycin ethylsuccinate generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Bryant Ranch Prepack	1d9eb7cb-0b11-4f6e-8a9c-1bcff37fe0b5	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: Erythromycin ethylsuccinate generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Kanchan Healthcare Inc	a7f7faaf-dc05-4d51-86c6-bf5d61562e48	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: Erythromycin ethylsuccinate generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin Ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	ANI Pharmaceuticals, Inc.	3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f	2025-06-20	Warnings, Adverse reactions	Name fallback brand name: Erythromycin Ethylsuccinate generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin Ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	ANI Pharmaceuticals, Inc.	3de1e0b9-473b-44c0-a644-5fa14ad69a83	2025-06-20	Warnings, Adverse reactions	Name fallback brand name: Erythromycin Ethylsuccinate generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin Ethylsuccinate	ERYTHROMYCIN	Amneal Pharmaceuticals NY LLC	581d7430-1a80-42a6-befb-4c3ae8140392	2025-04-25	Warnings, Adverse reactions	Name fallback brand name: Erythromycin Ethylsuccinate
Erythromycin Ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Nivagen Pharmaceuticals, Inc.	46f74c4f-10fc-44cf-aec4-d113f49149bc	2024-01-02	Warnings, Adverse reactions	Name fallback brand name: Erythromycin Ethylsuccinate generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin Ethylsuccinate	ERYTHROMYCIN	Amneal Pharmaceuticals NY LLC	596fa019-b0eb-4e57-93ff-195a765a2e91	2023-12-29	Warnings, Adverse reactions	Name fallback brand name: Erythromycin Ethylsuccinate
E.E.S 400	ERYTHROMYCIN ETHYLSUCCINATE	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	b455bbdb-a3f1-470f-aa5f-ed83ac2e228d	2023-12-16	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE
Ery-Ped	ERYTHROMYCIN ETHYLSUCCINATE	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	04775721-ab87-4b66-808c-d67a21032385	2023-12-16	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	23a0564e-dca9-41bc-b2c7-0461169f65f9	2023-12-16	Warnings, Adverse reactions	Name fallback brand name: ERYTHROMYCIN ETHYLSUCCINATE generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Cadila Pharmaceuticals Limited	db70798e-5e07-41d6-afe9-82c272bc5cc0	2023-11-11	Warnings, Adverse reactions	Name fallback brand name: Erythromycin ethylsuccinate generic name: ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	Wilshire Pharmaceuticals	86d6353c-2b58-4219-b31d-fb5b97789094	2020-09-24	Warnings, Adverse reactions	Name fallback brand name: ERYTHROMYCIN ETHYLSUCCINATE generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin Ethylsuccinate	ERYTHROMYCIN ETHYLSUCCINATE	Wilshire Pharmaceuticals Inc.	f4a3fffd-ce02-450f-bbcc-d425374e3e32	2019-01-29	Warnings, Adverse reactions	Name fallback brand name: Erythromycin Ethylsuccinate generic name: ERYTHROMYCIN ETHYLSUCCINATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0254-1020	Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	Par Pharmaceutical, Inc.	ANDA	Current
0254-1020	Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	Par Pharmaceutical, Inc.	ANDA	Current
0254-1020	Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	Par Pharmaceutical, Inc.	ANDA	Current
0254-1021	Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	Par Pharmaceutical, Inc.	ANDA	Current
0254-1021	Erythromycin Ethylsuccinate	Erythromycin Ethylsuccinate	Par Pharmaceutical, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61131	ORIG	2019-12-03