Application 078061

Type: ANDA
Sponsor: TEVA PHARMS USA

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
A078061-001	LINEZOLID	LINEZOLID	600MG	TABLET / ORAL			2015-05-18

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 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	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078061-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078061-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078061-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078061-001	LINEZOLID	600MG	TABLET / ORAL	AB	2015-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078061-001	LINEZOLID	600MG	TABLET / ORAL		2015-05-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078061-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078061-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078061-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078061-001	AB	1	`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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Linezolid	LINEZOLID	Macleods Pharmaceuticals Limited	90dd8c13-c428-4472-91e5-5b1fcdc4fce3	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Hikma Pharmaceuticals USA Inc.	16007ca5-7956-4414-af38-406a6623400e	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Eugia US LLC	b721756c-3b5e-456d-a2f6-0d8a56cc7f35	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Zyvox	LINEZOLID	Pharmacia & Upjohn Company LLC	3e5e9975-6f36-42e4-ab46-0e75dda83592	2026-07-09	Warnings, Adverse reactions	Name fallback generic name: LINEZOLID
Linezolid	LINEZOLID	Mylan Pharmaceuticals Inc.	374af2a7-d994-40bd-a86a-cd9038d0b72c	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Mylan Pharmaceuticals Inc.	83a84897-ccca-42a1-ab1a-bbf1d43a982b	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Sportpharm LLC	7368298b-d75c-4950-bbc1-00fc53f472ec	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Zyvox	LINEZOLID	Pharmacia & Upjohn Company LLC	6e70e63b-bfd5-478d-a8ee-8ba22c9efabd	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: LINEZOLID
Linezolid	LINEZOLID	Hospira, Inc.	c401f1a8-cc37-461b-bfef-f2e156629bf8	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	REMEDYREPACK INC.	3e0d868d-f419-47e8-a3bc-41ececac468b	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Sportpharm LLC	561abed1-c0f9-40ee-98a8-7c710bcde822	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Caplin Steriles Limited	2220c753-e0e8-4797-bce2-34b3c63bd631	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Major Pharmaceuticals	bef116a8-427d-4855-86de-0017e01430b0	2025-11-13	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
linezolid	LINEZOLID	Chartwell RX, LLC	9d1b4d0a-0fd9-448b-a28f-51ed05a5a0cf	2025-11-04	Warnings, Adverse reactions	Name fallback brand name: linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Piramal Critical Care Inc.	d05541c6-fd63-cc99-e053-2995a90a4ec7	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Piramal Critical Care Inc	95b8fd63-d018-8062-e053-2995a90ab96d	2025-09-25	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
Linezolid	LINEZOLID	Coupler LLC	3dff6eec-8662-335f-e063-6294a90ab159	2025-09-04	Warnings, Adverse reactions	Name fallback brand name: Linezolid generic name: LINEZOLID
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

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
0093-7490	Linezolid	Linezolid	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7490	Linezolid	Linezolid	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7490	Linezolid	Linezolid	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9111	ORIG	2015-05-20