Isoniazid

Sold as Nydrazid, Rimifon, Isoniazid. Every FDA application for this active ingredient: 6 branded and 39 generic.

As of Nov 14, 2026, FDA lists 45 applications for Isoniazid (sold as Nydrazid, Rimifon, Isoniazid), first approved Sep 29, 1952, with 0 new uses approved and 0 published complete response letters.

First approved: Sep 29, 1952
Applications: 45
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $1.1M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Isoniazid	Part D	$1.1M	+201%	12,661

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

ISONIAZID 100 MG TABLET: $1.73 per unitGeneric · new this year
ISONIAZID 300 MG TABLET: $3.32 per unitGeneric · +20% in a year

Clinical Trials

66 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Ablation Versus Non-ablation Strategies for Non-puerperal Mastitis: A Prospective Real-world Registry StudyNon-Puerperal Mastitis · Song Hongping	—	Recruiting	Oct 26, 2026
Latent Infection Freshmen Tracking for TuberculosisLatent Tuberculosis Infection (LTBI), Tuberculosis (TB) · Affiliated Hospital of Nantong University	Phase 4	Recruiting	Sep 10, 2026
Study of Combinations of Novel Promising Drugs for Pulmonary TuberculosisTuberculosis, Pulmonary · TASK Applied Science	Phase 2	Not yet recruiting	Aug 19, 2026
A Phase I Study Investigating the Local Tolerability and Pharmacokinetics of Isoniazid (INH) Inhalation by Wet Nebulization in Patients With TuberculosisTuberculosis · University Medical Center Groningen	Phase 1	Recruiting	Jul 16, 2026
Rifapentine-Based Shorter Regimens for Tuberculosis and TB Infection in KazakhstanTuberculosis, Tuberculosis Infection, Latent · Public Union "Kazakhstan Association of Phthisiopulmonologists"	—	Not yet recruiting	Jun 25, 2026
Re-evaluating the Duration in Children of TB TreatmentTuberculosis · University of Wisconsin, Madison	Phase 2	Not yet recruiting	Jun 18, 2026
Comparative Trial Between Ainuovirine(ANV)/Lamivudine(3TC)/Tenofovir(TDF) and Efavirenz(EFV)/Lamivudine/Tenofovir RegimensHIV, Art Therapy · Shanghai Public Health Clinical Center	Phase 4	Not yet recruiting	Jun 8, 2026
Short-Course Regimens for DS-PTB in AIDS PatientsTuberculosis in HIV-infected Individuals, Drug Susceptible Pulmonary Tuberculosis · Shanghai Public Health Clinical Center	Not applicable	Not yet recruiting	May 27, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 29, 1952	NydrazidNDA 8662 · New dosage form	Sandoz	12	Discontinued
Nov 17, 1952	IsoniazidNDA 8678 · New formulation or manufacturer	Epic Pharma LLC	20	Discontinued
Nov 13, 1970	IsoniazidANDA 80136	Sun Pharm Industries	13	Discontinued
Apr 14, 1971	IsoniazidANDA 80120	Whiteworth Town Plsn	2	Discontinued
Nov 4, 1971	Dow-IsoniazidANDA 80330	Dow Pharm	0	Discontinued
Jan 21, 1972	StanozideANDA 80126	Everylife	0	Discontinued
Feb 3, 1972	IsoniazidANDA 80523	Watson Labs	2	Discontinued
Feb 28, 1972	IsoniazidANDA 80212	Hikma	21	Discontinued
Feb 28, 1972	IsoniazidANDA 80522	Watson Labs	2	Discontinued
Feb 28, 1972	IsoniazidANDA 80521	Watson Labs	9	Discontinued
Mar 16, 1972	IsoniazidANDA 80941	Mk Labs	0	Discontinued
Aug 24, 1972	IsoniazidANDA 80936	Genus Lifesciences	26	Discontinued
Aug 24, 1972	IsoniazidANDA 80937	Genus Lifesciences	29	Discontinued
Aug 1, 1973	IsoniazidANDA 80153	Impax Labs	1	Discontinued
Jan 15, 1974	IsoniazidANDA 83610	Ivax Sub Teva Pharms	0	Discontinued
Oct 22, 1974	IsoniazidANDA 84050	Nexgen Pharma Inc	0	Discontinued
Aug 29, 1975	LaniazidANDA 80140	Chartwell Molecular	3	Discontinued
Dec 18, 1975	IsoniazidANDA 80368	Phoenix Labs Ny	0	Discontinued
May 11, 1976	IsoniazidANDA 83633	Sun Pharm Industries	14	Discontinued
Jul 29, 1976	IsoniazidANDA 85091	Pharmavite	0	Discontinued
Sep 9, 1977	IsoniazidANDA 85790	Watson Labs	0	Discontinued
Sep 9, 1977	IsoniazidANDA 85784	Watson Labs	0	Discontinued
Jul 14, 1981	IsoniazidANDA 87425	Hikma Intl Pharms	19	Discontinued
Mar 17, 1983	IsoniazidANDA 88119	Duramed Pharms Barr	12	Discontinued
Mar 17, 1983	IsoniazidANDA 88231	Duramed Pharms Barr	12	Discontinued
Nov 10, 1983	IsoniazidANDA 88235	Cmp Pharma Inc	7	Marketed
Feb 3, 1986	LaniazidANDA 89243	Lannett	5	Discontinued
Jun 13, 1988	LaniazidANDA 89776	Chartwell Molecular	15	Discontinued
Jun 26, 1997	IsoniazidANDA 40090	Omnivium Pharms	5	Marketed
Jul 21, 1997	IsoniazidANDA 81118	Chartwell Rx	3	Marketed
Jul 5, 2005	IsoniazidANDA 40648	Sandoz	2	Marketed
Oct 29, 2014	IsoniazidANDA 202610	Thepharmanetwork LLC	1	Marketed
—	NydrazidNDA 8392	Bristol Myers Squibb	0	Discontinued
—	RimifonNDA 8420	Roche	0	Discontinued
—	IsoniazidNDA 8499	Lilly	0	Discontinued
—	IsoniazidANDA 80132	Purepac Pharm	3	Discontinued
—	HyzydANDA 80134	Medpointe Pharm Hlc	0	Discontinued
—	IsoniazidANDA 80270	Ivax Sub Teva Pharms	0	Discontinued
—	IsoniazidANDA 80401	Watson Labs	0	Discontinued
—	InhANDA 80935	Novartis	0	Discontinued
—	IsoniazidANDA 83060	Perrigo	0	Discontinued
—	IsoniazidANDA 83178	Watson Labs	0	Discontinued
—	IsoniazidANDA 83632	Halsey	0	Discontinued
—	IsoniazidANDA 89816	Quad Pharms	0	Discontinued
—	IsoniazidNDA 8428	Panray	12	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA