Application 021130

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYVOX	LINEZOLID	TABLET;ORAL	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	ZYVOX	LINEZOLID	TABLET;ORAL	600MG	Yes	Yes

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

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
N021130-001	ZYVOX	LINEZOLID	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18
N021130-002	ZYVOX	LINEZOLID	600MG	TABLET / ORAL		RLD	2000-04-18

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 1 of 3 · 82 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UTC	2026-02	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021130-002	ZYVOX	600MG	TABLET / ORAL		RLD	2000-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021130-002	ZYVOX	600MG	TABLET / ORAL		RLD	2000-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	2000-04-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-04-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021130-001	ZYVOX	400MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	2000-04-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021130-002	ZYVOX	600MG	TABLET / ORAL	AB	RLD, RS	2000-04-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N021130-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021130-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021130-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021130-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021130-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021130-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021130-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021130-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021130-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021130-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021130-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021130-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021130-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021130-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021130-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021130-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021130-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021130-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021130-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021130-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021130-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021130-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021130-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021130-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021130-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021130-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021130-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021130-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021130-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021130-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021130-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021130-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021130-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021130-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021130-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021130-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021130-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021130-002	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021130-001	6559305	2021-01-29	Drug substance	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021130-001	6514529	2021-03-15	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021130-001	6559305*PED	2021-07-29	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021130-001	6514529*PED	2021-09-15	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021130-002	6559305	2021-01-29	Drug substance	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021130-002	6514529	2021-03-15	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021130-002	6559305*PED	2021-07-29	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021130-002	6514529*PED	2021-09-15	Pediatric extension	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021130-001	6559305	2021-01-29	Drug substance	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021130-001	6514529	2021-03-15	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021130-001	6559305*PED	2021-07-29	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021130-001	6514529*PED	2021-09-15	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021130-002	6559305	2021-01-29	Drug substance	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021130-002	6514529	2021-03-15	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021130-002	6559305*PED	2021-07-29	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021130-002	6514529*PED	2021-09-15	Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021130-001	6559305	2021-01-29	Drug substance	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021130-001	6514529	2021-03-15	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021130-001	6559305*PED	2021-07-29	Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021130-001	6514529*PED	2021-09-15	Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021130-002	6559305	2021-01-29	Drug substance	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021130-002	6514529	2021-03-15	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021130-002	6559305*PED	2021-07-29	Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021130-002	6514529*PED	2021-09-15	Pediatric extension	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021130-001	6559305	2021-01-29	Drug substance	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021130-001	6514529	2021-03-15	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021130-001	6559305*PED	2021-07-29	Pediatric extension	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021130-001	6514529*PED	2021-09-15	Pediatric extension	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021130-002	6559305	2021-01-29	Drug substance	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021130-002	6514529	2021-03-15	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021130-002	6559305*PED	2021-07-29	Pediatric extension	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021130-002	6514529*PED	2021-09-15	Pediatric extension	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021130-001	6559305	2021-01-29	Drug substance	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021130-001	6514529	2021-03-15	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021130-001	6559305*PED	2021-07-29	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021130-001	6514529*PED	2021-09-15	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021130-002	6559305	2021-01-29	Drug substance	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021130-002	6514529	2021-03-15	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021130-002	6559305*PED	2021-07-29	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021130-002	6514529*PED	2021-09-15	Pediatric extension	`8869cabd3fbd…`

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.	374af2a7-d994-40bd-a86a-cd9038d0b72c	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021130 application number: NDA021130 ndc (product): 59762-1307
Zyvox	LINEZOLID	Pharmacia & Upjohn Company LLC	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021130 application number: NDA021130 ndc (product): 0009-5138

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-5138	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5138	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5138	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5138	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5138	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5138	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5138	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5138	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5138	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5138	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5138	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5138	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0093-8244	LINEZOLID	Linezolid	Teva Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
21695-399	Zyvox	linezolid	Rebel Distributors Corp	NDA	Current
59762-1307	Linezolid	linezolid	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1307	Linezolid	linezolid	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1307	Linezolid	linezolid	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1307	Linezolid	linezolid	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1307	Linezolid	linezolid	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1307	Linezolid	linezolid	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
60505-4362	LINEZOLID	Linezolid	Apotex Corp.	NDA AUTHORIZED GENERIC	Current
70518-1226	Zyvox	linezolid	REMEDYREPACK INC.	NDA	Current
70518-1226	Zyvox	linezolid	REMEDYREPACK INC.	NDA	Current
70518-1226	Zyvox	linezolid	REMEDYREPACK INC.	NDA	Current
70518-1226	Zyvox	linezolid	REMEDYREPACK INC.	NDA	Current
70518-1226	Zyvox	linezolid	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78933	SUPPL	2024-06-28
78927	SUPPL	2024-06-28
74805	SUPPL	2023-07-20
74795	SUPPL	2023-07-19
69143	SUPPL	2021-10-27
69128	SUPPL	2021-10-27
68590	SUPPL	2021-09-13
68515	SUPPL	2021-09-02
68132	SUPPL	2021-07-20
68119	SUPPL	2021-07-19
64222	SUPPL	2020-08-06
64221	SUPPL	2020-08-06
64214	SUPPL	2020-08-06
64213	SUPPL	2020-08-06
52295	SUPPL	2018-02-02
52264	SUPPL	2018-02-02
48994	SUPPL	2017-07-14
48993	SUPPL	2017-07-14
26853	SUPPL	2015-06-10
14461	SUPPL	2015-06-10
41970	SUPPL	2014-07-07
4412	SUPPL	2014-01-28
36174	SUPPL	2014-01-27
36172	SUPPL	2013-05-09
14460	SUPPL	2013-05-09
4411	SUPPL	2013-05-07
4410	SUPPL	2013-05-07
26852	SUPPL	2012-02-15
36173	SUPPL	2012-02-14
4409	SUPPL	2010-07-23
36171	SUPPL	2010-07-19
4408	SUPPL	2010-01-26
14459	SUPPL	2009-12-11
14458	SUPPL	2008-06-26
26851	SUPPL	2008-06-24
26850	SUPPL	2008-06-24
14457	SUPPL	2007-05-01
4407	SUPPL	2007-05-01
4406	SUPPL	2005-11-08
41969	SUPPL	2005-06-27
36170	SUPPL	2005-05-17
26849	SUPPL	2005-05-17
26848	SUPPL	2005-05-17
14456	SUPPL	2005-05-17
26847	SUPPL	2005-02-11
26844	SUPPL	2004-07-01
26843	SUPPL	2004-07-01
14455	SUPPL	2004-06-25
4405	SUPPL	2004-06-25
26846	SUPPL	2004-01-14
26845	SUPPL	2003-07-28
14454	SUPPL	2003-04-07
14453	SUPPL	2003-04-07
41968	ORIG	2000-04-18
14452	ORIG	2000-04-18
4404	ORIG	2000-04-18
52025	ORIG	1900-01-01
52024	ORIG	1900-01-01
52023	ORIG	1900-01-01
52022	ORIG	1900-01-01
52021	ORIG	1900-01-01
52020	ORIG	1900-01-01
52019	ORIG	1900-01-01