Application 204696

Type: ANDA
Sponsor: SAGENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LINEZOLID	LINEZOLID	SOLUTION;INTRAVENOUS	200MG/100ML (2MG/ML)	No	No
002	LINEZOLID	LINEZOLID	SOLUTION;INTRAVENOUS	600MG/300ML (2MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A204696-001	LINEZOLID	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP		2017-03-02
A204696-002	LINEZOLID	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP		2017-03-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204696-001	AP
A204696-002	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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204696-001	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204696-002	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-03-02	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204696-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204696-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204696-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204696-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204696-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204696-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204696-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204696-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204696-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204696-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204696-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204696-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204696-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204696-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204696-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204696-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204696-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204696-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204696-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204696-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204696-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204696-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204696-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204696-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204696-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204696-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204696-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204696-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204696-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204696-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204696-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204696-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204696-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204696-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204696-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204696-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204696-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204696-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204696-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204696-002	AP	1	`74a2ff9319b5…`

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 2 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Linezolid	LINEZOLID	Bryant Ranch Prepack	8a04bdc9-d6f0-4e35-b683-a472a2e4ff04	2025-08-26	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Bryant Ranch Prepack	ab1b4ab5-7338-4b01-963b-43eeb4c9cf1c	2025-08-26	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Ascend Laboratories, LLC	7402aa01-50de-46c8-a341-d30da5b32b1c	2025-06-13	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Hikma Pharmaceuticals USA Inc.	fedbffa7-087d-4448-85c9-0350a3947080	2025-05-09	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Camber Pharmaceuticals, Inc.	b239458e-9a3e-49ac-9ac7-a4badc53dff6	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	American Health Packaging	bc12bd87-5ef0-4ebe-bc00-cbd7896ce08c	2024-11-22	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Lupin Pharmaceuticals,Inc.	b3c55eb4-50f2-47f0-a424-5a6779518e1d	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Hp Halden Pharma AS	217f3ee2-2534-4c32-8e9d-09b6d65df4af	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Zyvox	LINEZOLID	Hp Halden Pharma AS	b0c75e79-bf29-4f1d-a45d-ae28398a52d9	2024-05-28	Warnings, Adverse reactions	Name fallback generic name: LINEZOLID
Zyvox	LINEZOLID	Hp Halden Pharma AS	ce57225b-4580-442b-8c48-8045297cbb50	2024-05-28	Warnings, Adverse reactions	Name fallback generic name: LINEZOLID
Zyvox	LINEZOLID	Hp Halden Pharma AS	efe6818c-b798-4d1d-8196-6447a305ad71	2024-05-28	Warnings, Adverse reactions	Name fallback generic name: LINEZOLID
Linezolid	LINEZOLID	Fresenius Kabi USA, LLC	cc3e3ea4-50aa-49ee-a8bc-fb48bfc8e014	2024-04-30	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Camber Pharmaceuticals, Inc.	a89a37ec-a736-464b-a83a-84bef6ccd702	2023-09-15	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	American Health Packaging	e9ac1ad7-7a23-463d-a467-f0ecc7e523e7	2023-08-18	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Alembic Pharmaceuticals Limited	74f035ec-a0b1-4371-a17b-20b0b11864c9	2023-01-30	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Alembic Pharmaceuticals Inc.	ca930576-62ab-4af5-ac3e-27ca376baca6	2020-08-26	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-169	linezolid	linezolid	Sagent Pharmaceuticals	ANDA	Current
25021-169	linezolid	linezolid	Sagent Pharmaceuticals	ANDA	Current
25021-169	linezolid	linezolid	Sagent Pharmaceuticals	ANDA	Current