Application 214364

Type: ANDA
Sponsor: GLAND PHARMA LTD

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

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
A214364-001	SUGAMMADEX SODIUM	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2026-07-28
A214364-002	SUGAMMADEX SODIUM	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2026-07-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A214364-001	AP
A214364-002	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
2026-09-14 22:38:34	2026-08	A214364-001	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2026-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214364-002	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2026-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214364-001	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2026-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214364-002	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2026-07-28	`caaa826d4ba7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214364-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214364-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214364-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214364-002	AP	1	`caaa826d4ba7…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
sugammadex	SUGAMMADEX	Gland Pharma Limited	c61ee55a-e61b-4d3c-9ebc-cbf57290e36c	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214364 application number: ANDA214364
sugammadex	SUGAMMADEX	GLENMARK PHARMACEUTICALS INC., USA	e7897fc1-4553-460c-a29b-0bc91cd9ca10	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214364 application number: ANDA214364
sugammadex	SUGAMMADEX	Fosun Pharma USA Inc.	4f1c7cf8-3db7-3f92-e063-6394a90aece9	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214364 application number: ANDA214364

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69663	ORIG	2021-12-20