FDA Orange Book · active-ingredient family
Isoniazid
Isoniazid: 6 brands, 37 generics; first approved Jul 14, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 37 ANDA applications approved.
Brands (NDA)
6
Generics (ANDA)
37
Listed patents
0
Presentations
57
Brand (NDA) products
Originator applications
- ISONIAZIDRLDEPIC PHARMA LLCNDA 008678-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - 300MG TABLET ORAL Discontinued - - SANDOZNDA 008662-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued - - ROCHENDA 008420-3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Discontinued - 25MG/ML INJECTABLE INJECTION Discontinued - 100MG/ML INJECTABLE INJECTION Discontinued - - ISONIAZIDLILLYNDA 008499-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - 300MG TABLET ORAL Discontinued - - ISONIAZIDPANRAYNDA 008428-3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - 300MG TABLET ORAL Discontinued - - BRISTOL MYERS SQUIBBNDA 008392-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued -
Generic (ANDA) products (37)
Abbreviated applications
- ISONIAZIDTHEPHARMANETWORK LLCANDA 20261020142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AA 300MG TABLET ORAL Rx AA - ISONIAZIDRSSANDOZANDA 0406482005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Rx - - ISONIAZIDCHARTWELL RXANDA 0811181997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Rx AA - ISONIAZIDRSOMNIVIUM PHARMSANDA 04009019972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AA 300MG TABLET ORAL Rx AA - CHARTWELL MOLECULARANDA 0897761988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued - - LANNETTANDA 0892431986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Discontinued - - ISONIAZIDRLDRSCMP PHARMA INCANDA 0882351983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML SYRUP ORAL Rx AA - ISONIAZIDDURAMED PHARMS BARRANDA 0882311983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - ISONIAZIDDURAMED PHARMS BARRANDA 0881191983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued - - ISONIAZIDPUREPAC PHARMANDA 08013219822 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - - DOW PHARMANDA 080330-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued - - MEDPOINTE PHARM HLCANDA 080134-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - 300MG TABLET ORAL Discontinued - - NOVARTISANDA 080935-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued - - ISONIAZIDHALSEYANDA 083632-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - ISONIAZIDHIKMA INTL PHARMSANDA 080212-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - 300MG TABLET ORAL Discontinued - - ISONIAZIDIMPAX LABSANDA 080153-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - ISONIAZIDIVAX SUB TEVA PHARMSANDA 080270-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - ISONIAZIDIVAX SUB TEVA PHARMSANDA 083610-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued - - ISONIAZIDMK LABSANDA 080941-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - ISONIAZIDNEXGEN PHARMA INCANDA 084050-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - ISONIAZIDPERRIGOANDA 083060-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - ISONIAZIDPHARMAVITEANDA 085091-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - ISONIAZIDPHOENIX LABS NYANDA 080368-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - - ISONIAZIDSUN PHARM INDUSTRIESANDA 080136-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - ISONIAZIDSUN PHARM INDUSTRIESANDA 083633-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued - - ISONIAZIDWATSON LABSANDA 080522-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - ISONIAZIDWATSON LABSANDA 080401-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - ISONIAZIDWATSON LABSANDA 080523-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - ISONIAZIDWATSON LABSANDA 085790-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - ISONIAZIDWATSON LABSANDA 080521-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued - - ISONIAZIDWATSON LABSANDA 083178-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued - - ISONIAZIDWATSON LABSANDA 085784-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued - - ISONIAZIDWHITEWORTH TOWN PLSNANDA 080120-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - ISONIAZIDZETA PHARMSANDA 080936-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - - ISONIAZIDZETA PHARMSANDA 080937-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued - - CHARTWELL MOLECULARANDA 080140-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - - EVERYLIFEANDA 080126-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued - 300MG TABLET ORAL 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
44 yr 11 mo ago
Most recent approval
12 yr 2 mo ago
Approvals span 1982–2014 across 43 FDA applications.
Brand (NDA) 614%
Generic (ANDA) 3786%
Isoniazid: 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.
Assyro Intelligence
Ask anything about Isoniazid
Cited answers from FDA, EMA, Health Canada, PubMed and ClinicalTrials.gov, in seconds. Free, no sign-up.
Evaluating for a team? Book a demo