FDA.reportPublic FDA data

Application 206097

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LINEZOLIDLINEZOLIDTABLET;ORAL600MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206097-001LINEZOLIDLINEZOLID600MGTABLET / ORALAB2017-02-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206097-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A206097-001LINEZOLID600MGTABLET / ORALAB2017-02-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206097-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LinezolidLINEZOLIDHikma Pharmaceuticals USA Inc.16007ca5-7956-4414-af38-406a6623400e2026-07-15Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
LinezolidLINEZOLIDEugia US LLCb721756c-3b5e-456d-a2f6-0d8a56cc7f352026-07-13Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
ZyvoxLINEZOLIDPharmacia & Upjohn Company LLC3e5e9975-6f36-42e4-ab46-0e75dda835922026-07-09Warnings, Adverse reactionsName fallback
generic name: LINEZOLID
LinezolidLINEZOLIDMylan Pharmaceuticals Inc.374af2a7-d994-40bd-a86a-cd9038d0b72c2026-07-09Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
LinezolidLINEZOLIDMylan Pharmaceuticals Inc.83a84897-ccca-42a1-ab1a-bbf1d43a982b2026-07-09Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
LinezolidLINEZOLIDSportpharm LLC7368298b-d75c-4950-bbc1-00fc53f472ec2026-07-02Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
ZyvoxLINEZOLIDPharmacia & Upjohn Company LLC6e70e63b-bfd5-478d-a8ee-8ba22c9efabd2026-06-23Warnings, Adverse reactionsName fallback
generic name: LINEZOLID
LinezolidLINEZOLIDHospira, Inc.c401f1a8-cc37-461b-bfef-f2e156629bf82026-06-19Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
LinezolidLINEZOLIDREMEDYREPACK INC.3e0d868d-f419-47e8-a3bc-41ececac468b2026-06-12Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
LinezolidLINEZOLIDSportpharm LLC561abed1-c0f9-40ee-98a8-7c710bcde8222026-04-24Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
LinezolidLINEZOLIDCaplin Steriles Limited2220c753-e0e8-4797-bce2-34b3c63bd6312025-12-23Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
LinezolidLINEZOLIDMajor Pharmaceuticalsbef116a8-427d-4855-86de-0017e01430b02025-11-13Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
linezolidLINEZOLIDChartwell RX, LLC9d1b4d0a-0fd9-448b-a28f-51ed05a5a0cf2025-11-04Warnings, Adverse reactionsName fallback
brand name: linezolid
generic name: LINEZOLID
LinezolidLINEZOLIDPiramal Critical Care Inc.d05541c6-fd63-cc99-e053-2995a90a4ec72025-10-22Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
LinezolidLINEZOLIDPiramal Critical Care Inc95b8fd63-d018-8062-e053-2995a90ab96d2025-09-25Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
LinezolidLINEZOLIDCoupler LLC3dff6eec-8662-335f-e063-6294a90ab1592025-09-04Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
LinezolidLINEZOLIDBryant Ranch Prepack8a04bdc9-d6f0-4e35-b683-a472a2e4ff042025-08-26Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
LinezolidLINEZOLIDBryant Ranch Prepackab1b4ab5-7338-4b01-963b-43eeb4c9cf1c2025-08-26Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
LinezolidLINEZOLIDAscend Laboratories, LLC7402aa01-50de-46c8-a341-d30da5b32b1c2025-06-13Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID
LinezolidLINEZOLIDHikma Pharmaceuticals USA Inc.fedbffa7-087d-4448-85c9-0350a39470802025-05-09Warnings, Adverse reactionsName fallback
brand name: Linezolid
generic name: LINEZOLID

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-413LinezolidLinezolidZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-413LinezolidLinezolidZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-413LinezolidLinezolidZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1111LinezolidLinezolidCadila Healthcare LimitedANDACurrent
70771-1111LinezolidLinezolidZydus Lifesciences LimitedANDACurrent
70771-1111LinezolidLinezolidCadila Healthcare LimitedANDACurrent
70771-1111LinezolidLinezolidCadila Healthcare LimitedANDACurrent