Application 204239

Type: ANDA
Sponsor: HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LINEZOLID	LINEZOLID	TABLET;ORAL	600MG	No	No

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
A204239-001	LINEZOLID	LINEZOLID	600MG	TABLET / ORAL	AB		2015-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204239-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204239-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-12-21	`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	A204239-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204239-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204239-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204239-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204239-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204239-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204239-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204239-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204239-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204239-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204239-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204239-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204239-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204239-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204239-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204239-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204239-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204239-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204239-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204239-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204239-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204239-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204239-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204239-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204239-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204239-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204239-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204239-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204239-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204239-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204239-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204239-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204239-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204239-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204239-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204239-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204239-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204239-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204239-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204239-001	AB	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Linezolid	LINEZOLID	Coupler LLC	3dff6eec-8662-335f-e063-6294a90ab159	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204239 application number: ANDA204239
Linezolid	LINEZOLID	Bryant Ranch Prepack	8a04bdc9-d6f0-4e35-b683-a472a2e4ff04	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204239 application number: ANDA204239 ndc (product): 63629-8576
Linezolid	LINEZOLID	Camber Pharmaceuticals, Inc.	b239458e-9a3e-49ac-9ac7-a4badc53dff6	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204239 application number: ANDA204239 ndc (product): 31722-749
Linezolid	LINEZOLID	American Health Packaging	bc12bd87-5ef0-4ebe-bc00-cbd7896ce08c	2024-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204239 application number: ANDA204239 ndc (product): 60687-309

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-749	Linezolid	Linezolid	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-749	Linezolid	Linezolid	Camber Pharmaceuticals, Inc.	ANDA	Current
60687-309	Linezolid	Linezolid	American Health Packaging	ANDA	Current
60687-309	Linezolid	Linezolid	American Health Packaging	ANDA	Current
60687-309	Linezolid	Linezolid	American Health Packaging	ANDA	Current
60687-309	Linezolid	Linezolid	American Health Packaging	ANDA	Current
63629-8576	Linezolid	Linezolid	Bryant Ranch Prepack	ANDA	Current
70518-0527	Linezolid	Linezolid	REMEDYREPACK INC.	ANDA	Current
70518-0527	Linezolid	Linezolid	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10310	ORIG	2015-12-22
32525	ORIG	2015-04-13