Application 211086

Type: ANDA
Sponsor: EXELA PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERYTHROMYCIN LACTOBIONATE	ERYTHROMYCIN LACTOBIONATE	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211086-001	ERYTHROMYCIN LACTOBIONATE	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			2020-09-17

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-09-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-09-17	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-09-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-09-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211086-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-09-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211086-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211086-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211086-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211086-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211086-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211086-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211086-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211086-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211086-001	AP	1	`c0c555d07b60…`
2023-05-13 08:27 UTC	2023-05	A211086-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211086-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211086-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211086-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211086-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211086-001	AP	1	`cb3db0bc1861…`

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 Lactobionate	ERYTHROMYCIN LACTOBIONATE	Piramal Critical Care Inc.	ee345752-0f0c-c69b-e053-2995a90a7dac	2026-08-16	Warnings, Adverse reactions	Name fallback brand name: Erythromycin Lactobionate generic name: ERYTHROMYCIN LACTOBIONATE
Erythromycin Lactobionate	ERYTHROMYCIN LACTOBIONATE	Armas Pharmaceuticals Inc.	ca65a48f-5fe6-4b31-8359-51dbc31f6d4e	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Erythromycin Lactobionate generic name: ERYTHROMYCIN LACTOBIONATE
Erythrocin Lactobionate	ERYTHROMYCIN LACTOBIONATE	Hospira, Inc.	a96c405f-bd70-4bb4-719e-ac6a79dcc213	2025-10-30	Warnings, Adverse reactions	Name fallback generic name: ERYTHROMYCIN LACTOBIONATE
erythromycin lactobionate	ERYTHROMYCIN LACTOBIONATE	Gland Pharma Limited	c6f9565b-6d9d-40e3-87f8-9f38ede9173a	2024-11-20	Warnings, Adverse reactions	Name fallback brand name: erythromycin lactobionate generic name: ERYTHROMYCIN LACTOBIONATE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51754-7000	Erythromycin Lactobionate	ERYTHROMYCIN LACTOBIONATE	Exela Pharma Sciences, LLC	ANDA	Current