Assyro AI

FDA Orange Book · active-ingredient family

Isoniazid

Isoniazid is approved as 6 brand and 38 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ISONIAZID · NDA 008678

6

Brand (NDA)

38

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, syrup, tablet

ProductApplicantApplicationTEApproved
ISONIAZIDRLD×2EPIC PHARMA LLCNDA 008678—Approved Prior to Jan 1, 1982
NYDRAZIDSANDOZNDA 008662—Approved Prior to Jan 1, 1982
RIMIFON×3ROCHENDA 008420—Approved Prior to Jan 1, 1982
ISONIAZID×2LILLYNDA 008499—Approved Prior to Jan 1, 1982
ISONIAZID×3PANRAYNDA 008428—Approved Prior to Jan 1, 1982
NYDRAZIDBRISTOL MYERS SQUIBBNDA 008392—Approved Prior to Jan 1, 1982

Generic (ANDA) products (38)

ProductApplicantApplicationTEApproved
ISONIAZID×2THEPHARMANETWORK LLCANDA 202610AAOct 29, 2014
ISONIAZIDSANDOZANDA 040648—Jul 05, 2005
ISONIAZIDCHARTWELL RXANDA 081118AAJul 21, 1997
ISONIAZID×2OMNIVIUM PHARMSANDA 040090AAJun 26, 1997
LANIAZIDCHARTWELL MOLECULARANDA 089776—Jun 13, 1988
LANIAZIDLANNETTANDA 089243—Feb 03, 1986
ISONIAZIDRLDCMP PHARMA INCANDA 088235AANov 10, 1983
ISONIAZIDDURAMED PHARMS BARRANDA 088231—Mar 17, 1983
ISONIAZIDDURAMED PHARMS BARRANDA 088119—Mar 17, 1983
ISONIAZID×2PUREPAC PHARMANDA 080132—Jul 14, 1982
DOW-ISONIAZIDDOW PHARMANDA 080330—Approved Prior to Jan 1, 1982
HYZYD×2MEDPOINTE PHARM HLCANDA 080134—Approved Prior to Jan 1, 1982
INHNOVARTISANDA 080935—Approved Prior to Jan 1, 1982
ISONIAZIDGENUSANDA 080936—Approved Prior to Jan 1, 1982
ISONIAZIDGENUSANDA 080937—Approved Prior to Jan 1, 1982
ISONIAZIDHALSEYANDA 083632—Approved Prior to Jan 1, 1982
ISONIAZIDHIKMA INTL PHARMSANDA 080212—Approved Prior to Jan 1, 1982
ISONIAZIDHIKMA INTL PHARMSANDA 087425—Approved Prior to Jan 1, 1982
ISONIAZIDIMPAX LABSANDA 080153—Approved Prior to Jan 1, 1982
ISONIAZIDIVAX SUB TEVA PHARMSANDA 080270—Approved Prior to Jan 1, 1982
ISONIAZIDIVAX SUB TEVA PHARMSANDA 083610—Approved Prior to Jan 1, 1982
ISONIAZIDMK LABSANDA 080941—Approved Prior to Jan 1, 1982
ISONIAZIDNEXGEN PHARMA INCANDA 084050—Approved Prior to Jan 1, 1982
ISONIAZIDPERRIGOANDA 083060—Approved Prior to Jan 1, 1982
ISONIAZIDPHARMAVITEANDA 085091—Approved Prior to Jan 1, 1982
ISONIAZID×2PHOENIX LABS NYANDA 080368—Approved Prior to Jan 1, 1982
ISONIAZIDSUN PHARM INDUSTRIESANDA 080136—Approved Prior to Jan 1, 1982
ISONIAZIDSUN PHARM INDUSTRIESANDA 083633—Approved Prior to Jan 1, 1982
ISONIAZIDWATSON LABSANDA 080522—Approved Prior to Jan 1, 1982
ISONIAZIDWATSON LABSANDA 080401—Approved Prior to Jan 1, 1982
ISONIAZIDWATSON LABSANDA 080523—Approved Prior to Jan 1, 1982
ISONIAZIDWATSON LABSANDA 085790—Approved Prior to Jan 1, 1982
ISONIAZIDWATSON LABSANDA 080521—Approved Prior to Jan 1, 1982
ISONIAZIDWATSON LABSANDA 083178—Approved Prior to Jan 1, 1982
ISONIAZIDWATSON LABSANDA 085784—Approved Prior to Jan 1, 1982
ISONIAZIDWHITEWORTH TOWN PLSNANDA 080120—Approved Prior to Jan 1, 1982
LANIAZID×2CHARTWELL MOLECULARANDA 080140—Approved Prior to Jan 1, 1982
STANOZIDE×2EVERYLIFEANDA 080126—Approved Prior to Jan 1, 1982

Listed patents

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.

Isoniazid — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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