Application 215260

Type: ANDA
Sponsor: TAMARANG SA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUGAMMADEX	SUGAMMADEX	INJECTION	100MG/1ML	No	No

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
A215260-001	SUGAMMADEX SODIUM	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2026-07-28
A215260-002	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
A215260-001	AP
A215260-002	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	A215260-001	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	A215260-002	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	A215260-001	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	A215260-002	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	A215260-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215260-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215260-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215260-002	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	Medical Purchasing Solutions, LLC	5b14e457-5ea1-3fe2-e063-6294a90aff6f	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215260 application number: ANDA215260
sugammadex	SUGAMMADEX SODIUM	Solupharm Pharmazeutische Erzeugnisse GmbH	f92c4e53-13d1-46f2-acf8-6730c3cfac69	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215260 application number: ANDA215260
sugammadex	SUGAMMADEX	Somerset Therapeutics, LLC	70c00636-d4ba-4939-802c-9d5a92435c93	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215260 application number: ANDA215260

Reported adverse events (FAERS/openFDA)#

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