Application 021132

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYVOX	LINEZOLID	FOR SUSPENSION;ORAL	100MG/5ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021132-001	ZYVOX	LINEZOLID	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021132-001	AB

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 1 of 2 · 41 observed 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
2026-02-19 14:30 UTC	2026-02	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021132-001	ZYVOX	100MG/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	2000-04-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021132-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021132-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021132-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021132-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021132-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021132-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021132-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021132-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021132-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021132-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021132-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021132-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021132-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021132-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021132-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021132-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021132-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021132-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021132-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021132-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021132-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021132-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021132-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021132-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021132-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021132-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021132-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021132-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021132-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021132-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021132-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021132-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021132-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021132-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021132-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021132-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021132-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021132-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021132-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021132-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021132-001	6559305	2021-01-29	Drug substance	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021132-001	6559305	2021-01-29	Drug substance	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021132-001	6559305	2021-01-29	Drug substance	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021132-001	6559305	2021-01-29	Drug substance	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021132-001	6559305	2021-01-29	Drug substance	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021132-001	6559305	2021-01-29	Drug substance	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021132-001	6559305	2021-01-29	Drug substance	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021132-001	6559305	2021-01-29	Drug substance	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021132-001	6559305	2021-01-29	Drug substance	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021132-001	6559305*PED	2021-07-29	Pediatric extension	`ea99ee380514…`

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
Linezolid	LINEZOLID	Mylan Pharmaceuticals Inc.	83a84897-ccca-42a1-ab1a-bbf1d43a982b	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021132 application number: NDA021132 ndc (product): 59762-1308
Zyvox	LINEZOLID	Pharmacia & Upjohn Company LLC	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021132 application number: NDA021132 ndc (product): 0009-5136

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-5136	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5136	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5136	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5136	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5136	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5136	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5136	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5136	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5136	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5136	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5136	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5136	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
55695-009	Zyvox	linezolid	Department of State Health Services, Pharmacy Branch	NDA	Current
59762-1308	Linezolid	linezolid	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1308	Linezolid	linezolid	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1308	Linezolid	linezolid	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1308	Linezolid	linezolid	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1308	Linezolid	linezolid	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1308	Linezolid	linezolid	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78935	SUPPL	2024-06-28
78929	SUPPL	2024-06-28
74807	SUPPL	2023-07-20
74797	SUPPL	2023-07-19
69145	SUPPL	2021-10-27
69130	SUPPL	2021-10-27
68592	SUPPL	2021-09-13
68517	SUPPL	2021-09-02
68134	SUPPL	2021-07-20
64226	SUPPL	2020-08-06
64225	SUPPL	2020-08-06
64218	SUPPL	2020-08-06
64217	SUPPL	2020-08-06
52297	SUPPL	2018-02-02
52266	SUPPL	2018-02-02
48996	SUPPL	2017-07-14
48991	SUPPL	2017-07-14
14472	SUPPL	2015-06-10
4433	SUPPL	2015-06-10
41973	SUPPL	2014-07-07
26872	SUPPL	2014-01-28
36193	SUPPL	2014-01-27
36191	SUPPL	2013-05-09
14471	SUPPL	2013-05-09
26871	SUPPL	2013-05-07
4431	SUPPL	2013-05-07
4432	SUPPL	2012-02-15
36192	SUPPL	2012-02-14
4430	SUPPL	2010-07-23
36190	SUPPL	2010-07-19
26870	SUPPL	2010-01-26
36189	SUPPL	2009-12-11
36188	SUPPL	2008-06-26
26869	SUPPL	2008-06-24
4429	SUPPL	2008-06-24
36187	SUPPL	2007-05-01
26868	SUPPL	2007-05-01
4428	SUPPL	2005-11-08
21467	SUPPL	2005-07-11
36186	SUPPL	2005-05-17
36185	SUPPL	2005-05-17
26867	SUPPL	2005-05-17
4427	SUPPL	2005-05-17
26866	SUPPL	2005-02-11
26863	SUPPL	2004-07-01
4425	SUPPL	2004-07-01
14470	SUPPL	2004-06-25
4426	SUPPL	2004-06-25
26865	SUPPL	2004-01-14
26864	SUPPL	2003-07-28
14469	SUPPL	2003-04-07
14468	SUPPL	2003-04-07
41972	ORIG	2000-04-18
36184	ORIG	2000-04-18
26862	ORIG	2000-04-18