Application 214290

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUGAMMADEX	SUGAMMADEX	INJECTABLE;INJECTION	200MG/2ML(100MG/ML)	No	No
002	SUGAMMADEX	SUGAMMADEX	INJECTABLE;INJECTION	500MG/2ML(100MG/ML)	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
A214290-001	SUGAMMADEX SODIUM	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2023-10-04
A214290-002	SUGAMMADEX SODIUM	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2023-10-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214290-001	AP
A214290-002	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.

Product history page 2 of 2 · 46 observed 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
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214290-001	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-04	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214290-002	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214290-001	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-04	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214290-002	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-04	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214290-001	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214290-002	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-10-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A214290-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A214290-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214290-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214290-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214290-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214290-002	AP	1	`caaa826d4ba7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214290-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214290-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214290-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214290-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214290-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214290-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214290-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214290-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214290-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214290-002	AP	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214290-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214290-002	AP	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sugammadex	SUGAMMADEX	Zydus Pharmaceuticals USA Inc.	21028965-598b-4cfa-a614-5c28ed40306a	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214290 application number: ANDA214290
Sugammadex	SUGAMMADEX	Zydus Lifesciences Limited	b1ec2b5e-a571-4511-ab44-d4193441330a	2026-07-02		Exact identifier application applno (ANDA): 214290 application number: ANDA214290

Reported adverse events (FAERS/openFDA)#

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