Application 021131

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYVOX	LINEZOLID	SOLUTION;INTRAVENOUS	200MG/100ML (2MG/ML)	Yes	No
002	ZYVOX	LINEZOLID	SOLUTION;INTRAVENOUS	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	ZYVOX	LINEZOLID	SOLUTION;INTRAVENOUS	600MG/300ML (2MG/ML)	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021131-001	ZYVOX	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18
N021131-002	ZYVOX	LINEZOLID	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18
N021131-003	ZYVOX	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021131-001	AP
N021131-003	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.

Product history page 1 of 4 · 123 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	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021131-002	ZYVOX	400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2000-04-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021131-003	ZYVOX	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021131-001	ZYVOX	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2000-04-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N021131-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021131-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021131-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021131-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021131-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021131-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021131-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021131-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021131-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021131-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021131-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021131-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021131-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021131-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021131-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021131-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021131-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021131-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021131-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021131-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021131-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021131-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021131-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021131-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021131-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021131-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021131-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021131-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021131-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021131-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021131-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021131-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021131-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021131-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021131-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021131-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021131-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021131-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021131-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021131-003	AP	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021131-001	6559305	2021-01-29	Drug substance		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021131-001	6559305*PED	2021-07-29	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021131-002	6559305	2021-01-29	Drug substance	2003-08-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021131-002	6559305*PED	2021-07-29	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021131-003	6559305	2021-01-29	Drug substance	2003-08-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021131-003	6559305*PED	2021-07-29	Pediatric extension		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021131-001	6559305	2021-01-29	Drug substance		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021131-001	6559305*PED	2021-07-29	Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021131-002	6559305	2021-01-29	Drug substance	2003-08-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021131-002	6559305*PED	2021-07-29	Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021131-003	6559305	2021-01-29	Drug substance	2003-08-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021131-003	6559305*PED	2021-07-29	Pediatric extension		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021131-001	6559305	2021-01-29	Drug substance		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021131-001	6559305*PED	2021-07-29	Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021131-002	6559305	2021-01-29	Drug substance	2003-08-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021131-002	6559305*PED	2021-07-29	Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021131-003	6559305	2021-01-29	Drug substance	2003-08-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021131-003	6559305*PED	2021-07-29	Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021131-001	6559305	2021-01-29	Drug substance		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021131-001	6559305*PED	2021-07-29	Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021131-002	6559305	2021-01-29	Drug substance	2003-08-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021131-002	6559305*PED	2021-07-29	Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021131-003	6559305	2021-01-29	Drug substance	2003-08-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021131-003	6559305*PED	2021-07-29	Pediatric extension		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021131-001	6559305	2021-01-29	Drug substance		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021131-001	6559305*PED	2021-07-29	Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021131-002	6559305	2021-01-29	Drug substance	2003-08-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021131-002	6559305*PED	2021-07-29	Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021131-003	6559305	2021-01-29	Drug substance	2003-08-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021131-003	6559305*PED	2021-07-29	Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021131-001	6559305	2021-01-29	Drug substance		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021131-001	6559305*PED	2021-07-29	Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021131-002	6559305	2021-01-29	Drug substance	2003-08-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021131-002	6559305*PED	2021-07-29	Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021131-003	6559305	2021-01-29	Drug substance	2003-08-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021131-003	6559305*PED	2021-07-29	Pediatric extension		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021131-001	6559305	2021-01-29	Drug substance		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021131-001	6559305*PED	2021-07-29	Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021131-002	6559305	2021-01-29	Drug substance	2003-08-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021131-002	6559305*PED	2021-07-29	Pediatric extension		`3f01610625f2…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zyvox	LINEZOLID	Pharmacia & Upjohn Company LLC	3e5e9975-6f36-42e4-ab46-0e75dda83592	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021131 application number: NDA021131 ndc (product): 0009-7807
Zyvox	LINEZOLID	Pharmacia & Upjohn Company LLC	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021131 application number: NDA021131 ndc (product): 0009-5137 ndc (product): 0009-5140
Zyvox	LINEZOLID	Hp Halden Pharma AS	b0c75e79-bf29-4f1d-a45d-ae28398a52d9	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021131 application number: NDA021131 ndc (product): 66298-7807
Zyvox	LINEZOLID	Hp Halden Pharma AS	ce57225b-4580-442b-8c48-8045297cbb50	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021131 application number: NDA021131 ndc (product): 66298-5137
Zyvox	LINEZOLID	Hp Halden Pharma AS	efe6818c-b798-4d1d-8196-6447a305ad71	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021131 application number: NDA021131 ndc (product): 66298-5140

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-4992	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-4992	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-4992	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-4992	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-4992	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-4992	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-4992	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-4992	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-4992	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5137	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5137	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5137	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5137	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5137	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5137	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5137	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5137	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5137	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5137	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5137	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5137	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5140	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5140	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5140	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5140	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5140	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5140	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5140	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5140	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5140	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-5140	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5140	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-5140	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-7807	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-7807	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-7807	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-7807	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
0009-7807	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-7807	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-7807	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-7807	Zyvox	linezolid	Pharmacia and Upjohn Company LLC	NDA	Current
0009-7807	Zyvox	linezolid	Pharmacia & Upjohn Company LLC	NDA	Current
66298-4992	Zyvox	LINEZOLID	Fresenius Kabi Norge As	NDA	Current
66298-5137	Zyvox	LINEZOLID	Fresenius Kabi Norge As	NDA	Current
66298-5140	Zyvox	linezolid	Fresenius Kabi Norge As	NDA	Current
66298-7807	Zyvox	LINEZOLID	Fresenius Kabi Norge As	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78934	SUPPL	2024-06-28
78928	SUPPL	2024-06-28
74806	SUPPL	2023-07-20
74796	SUPPL	2023-07-19
69296	SUPPL	2021-11-12
69292	SUPPL	2021-11-12
69144	SUPPL	2021-10-27
69129	SUPPL	2021-10-27
68591	SUPPL	2021-09-13
68516	SUPPL	2021-09-02
68133	SUPPL	2021-07-20
68120	SUPPL	2021-07-19
64224	SUPPL	2020-08-06
64223	SUPPL	2020-08-06
64216	SUPPL	2020-08-06
64215	SUPPL	2020-08-06
52296	SUPPL	2018-02-02
52265	SUPPL	2018-02-02
48995	SUPPL	2017-07-14
48992	SUPPL	2017-07-14
36183	SUPPL	2015-06-10
4424	SUPPL	2015-06-10
21466	SUPPL	2014-07-07
4423	SUPPL	2014-01-28
14467	SUPPL	2014-01-27
14466	SUPPL	2013-05-09
14465	SUPPL	2013-05-09
26860	SUPPL	2013-05-07
4422	SUPPL	2013-05-07
26861	SUPPL	2012-02-15
36182	SUPPL	2012-02-14
4421	SUPPL	2010-07-23
36181	SUPPL	2010-07-16
26859	SUPPL	2010-01-26
36180	SUPPL	2009-12-11
36179	SUPPL	2008-06-26
4420	SUPPL	2008-06-24
4419	SUPPL	2008-06-24
36178	SUPPL	2007-05-01
4418	SUPPL	2007-05-01
4417	SUPPL	2005-11-08
41971	SUPPL	2005-07-11
36177	SUPPL	2005-05-17
26858	SUPPL	2005-05-17
26857	SUPPL	2005-05-17
14464	SUPPL	2005-05-17
26856	SUPPL	2005-02-11
26854	SUPPL	2004-07-01
4414	SUPPL	2004-07-01
14463	SUPPL	2004-06-25
4416	SUPPL	2004-06-25
26855	SUPPL	2004-01-14
4415	SUPPL	2003-07-28
36176	SUPPL	2003-04-07
36175	SUPPL	2003-04-07
21465	ORIG	2000-04-18
14462	ORIG	2000-04-18
4413	ORIG	2000-04-18