Application 216761

Type: ANDA
Sponsor: GLAND

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 1.

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
A216761-001	ERYTHROMYCIN LACTOBIONATE	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2024-11-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216761-001	AP

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
2026-02-19 14:30 UTC	2026-02	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216761-001	ERYTHROMYCIN LACTOBIONATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2024-11-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216761-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216761-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216761-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216761-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216761-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216761-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216761-001	AP	1	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216761-001	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 Lactobionate	ERYTHROMYCIN LACTOBIONATE	Armas Pharmaceuticals Inc.	ca65a48f-5fe6-4b31-8359-51dbc31f6d4e	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216761 application number: ANDA216761
erythromycin lactobionate	ERYTHROMYCIN LACTOBIONATE	Gland Pharma Limited	c6f9565b-6d9d-40e3-87f8-9f38ede9173a	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216761 application number: ANDA216761