FDA Orange Book · active-ingredient family
Linezolid
Linezolid: 4 brands, 25 generics; first approved Apr 18, 2000; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 25 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
25
Listed patents
0
Presentations
37
Brand (NDA) products
Originator applications
- HOSPIRANDA 2064732015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/300ML (2MG/ML) SOLUTION INTRAVENOUS Rx — - PFIZERNDA 0211322000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML FOR SUSPENSION ORAL Rx AB - ZYVOXRLDPFIZERNDA 02113120003 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP 400MG/200ML (2MG/ML) SOLUTION INTRAVENOUS Discontinued — 600MG/300ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP - ZYVOXRLDPFIZERNDA 02113020002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 600MG TABLET ORAL Discontinued —
Generic (ANDA) products (25)
Abbreviated applications
- LINEZOLIDCAPLINANDA 2195582025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/300ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP - LINEZOLIDMACLEODS PHARMSANDA 2103782024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - LINEZOLIDHETERO LABSANDA 2118132022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML FOR SUSPENSION ORAL Rx AB - LINEZOLIDHIKMAANDA 2064542022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/300ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP - LINEZOLIDCHARTWELL RXANDA 2107022019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - LINEZOLIDSEROVIAANDA 20515420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP 600MG/300ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP - LINEZOLIDHQ SPCLT PHARMAANDA 20700120172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP 600MG/300ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP - LINEZOLIDSAGENT PHARMS INCANDA 20469620172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP 600MG/300ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP - LINEZOLIDZYDUS PHARMSANDA 2060972017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - LINEZOLIDNANG KUANG PHARM COANDA 20735420162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP 600MG/300ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP - LINEZOLIDNOVEL LABS INCANDA 2075262016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - LINEZOLIDEUGIA PHARMAANDA 2069172016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/300ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP - LINEZOLIDFRESENIUS KABI USAANDA 2047642016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/300ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP - LINEZOLIDGATE PHARMSANDA 0912102016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — - LINEZOLIDALEMBICANDA 2052332015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - LINEZOLIDRSALKEM LABS LTDANDA 2055172015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - LINEZOLIDAMNEAL PHARMSANDA 2045362015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — - LINEZOLIDGLENMARK SPECLTANDA 0789872015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - LINEZOLIDHETERO LABS LTD VANDA 2042392015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - LINEZOLIDRISINGANDA 0788452015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - LINEZOLIDSANDOZANDA 20090420152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP 600MG/300ML (2MG/ML) SOLUTION INTRAVENOUS Rx AP - LINEZOLIDHOSPIRAANDA 2054422015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/300ML (2MG/ML) SOLUTION INTRAVENOUS Discontinued — - LINEZOLIDHIKMAANDA 2000682015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML FOR SUSPENSION ORAL Rx AB - LINEZOLIDTEVA PHARMS USAANDA 0780612015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — - LINEZOLIDTEVA PHARMSANDA 2002222012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/300ML (2MG/ML) SOLUTION INTRAVENOUS Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
26 yr 10 mo ago
Most recent approval
10 mo ago
Approvals span 2000–2025 across 29 FDA applications.
Brand (NDA) 414%
Generic (ANDA) 2586%
Linezolid: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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