Application 213915

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUGAMMADEX	SUGAMMADEX SODIUM	INJECTABLE;INJECTION	200MG/2ML(100MG/ML)	No	No
002	SUGAMMADEX	SUGAMMADEX SODIUM	INJECTABLE;INJECTION	500MG/5ML(100MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A213915-001	SUGAMMADEX SODIUM	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2026-07-28
A213915-002	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
A213915-001	AP
A213915-002	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
2026-08-18 06:07:40	2026-07	A213915-001	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	A213915-002	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2026-07-28	`caaa826d4ba7…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213915-001	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-06-15	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213915-002	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213915-001	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-06-15	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213915-002	SUGAMMADEX SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-06-15	`a67488948f0b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213915-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213915-002	AP	1	`caaa826d4ba7…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213915-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213915-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213915-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213915-002	AP	1	`a67488948f0b…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sugammadex	SUGAMMADEX	Mylan Institutional LLC	eb84def8-933b-4eba-b81f-30d40b1e3d8d	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213915 application number: ANDA213915

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72944	ORIG	2022-12-20