Application 215575

Type: ANDA
Sponsor: QILU PHARM HAINAN

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
A215575-001	SUGAMMADEX SODIUM	SUGAMMADEX SODIUM	EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2026-07-28
A215575-002	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
A215575-001	AP
A215575-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215575-001	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	A215575-002	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
2026-08-18 06:07:40	2026-07	A215575-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215575-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sugammadex	SUGAMMADEX SODIUM	Sagent Pharmaceuticals	5b25f16e-726a-4464-88da-b188c2f4e038	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215575 application number: ANDA215575