Application 206473

Type: NDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	LINEZOLID	SOLUTION;INTRAVENOUS	600MG/300ML (2MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-06-18

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206473-001	LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-06-18	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Linezolid	LINEZOLID	Hospira, Inc.	c401f1a8-cc37-461b-bfef-f2e156629bf8	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206473 application number: NDA206473 ndc (product): 0409-4883

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-4883	Linezolid	LINEZOLID	Hospira, Inc.	NDA	Current
0409-4883	Linezolid	LINEZOLID	Hospira, Inc.	NDA	Current
0409-4883	Linezolid	LINEZOLID	Hospira, Inc.	NDA	Current
0409-4883	Linezolid	LINEZOLID	Hospira, Inc.	NDA	Current
0409-4883	Linezolid	LINEZOLID	Hospira, Inc.	NDA	Current
0409-4883	Linezolid	LINEZOLID	Hospira, Inc.	NDA	Current
0409-4883	Linezolid	LINEZOLID	Hospira, Inc.	NDA	Current
0409-4883	Linezolid	LINEZOLID	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82470	SUPPL	2025-06-05
82362	SUPPL	2025-05-30
80196	SUPPL	2024-11-12
80190	SUPPL	2024-11-12
70209	SUPPL	2022-02-22
70187	SUPPL	2022-02-18
69919	SUPPL	2022-01-19
69911	SUPPL	2022-01-19
68367	SUPPL	2021-08-13
68365	SUPPL	2021-08-13
68262	SUPPL	2021-08-02
68242	SUPPL	2021-08-02
55312	SUPPL	2018-08-24
55274	SUPPL	2018-08-23
50833	SUPPL	2017-12-22
50785	SUPPL	2017-12-20
23021	ORIG	2016-07-19
10573	ORIG	2015-06-22
40550	ORIG	2015-06-19