Application 062993

Type: ANDA
Sponsor: BAXTER HLTHCARE

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
002	ERYTHROMYCIN LACTOBIONATE	ERYTHROMYCIN LACTOBIONATE	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A062993-001	ERYTHROMYCIN LACTOBIONATE	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1989-05-09
A062993-002	ERYTHROMYCIN LACTOBIONATE	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			1989-05-09

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062993-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062993-002	ERYTHROMYCIN LACTOBIONATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1989-05-09	`3a93d1ddd44b…`

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.