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ISONIAZID

NDA

ISONIAZID | N008678 | EPIC PHARMA LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Macleods Pharmaceuticals Limited FDA-2018-P-1484 Macleods Pharmaceuticals Limited filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate an alternative reference standard for Isoniazid Tablets at 100 mg and 300 mg strengths, specifically requesting that ANDA #A080937 for Isoni	Other	2018-04-12	Denied	Macleods Pharmaceuticals Limited

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs2 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

YUKI GOSEI KOGYO CO LTDISONIAZID BULK FORM

DMF 47721982

YANGZHOU PHARMACEUTICAL CO LTDISONIAZID

DMF 162352002

CALYX CHEMICALS AND PHARMACEUTICALS LTDISONIAZID

DMF 213222008

BAYER CORPInactiveISONIAZID (NEOTEBEN)

DMF 58901985

BEIJING SECOND PHARMACEUTICAL FACTORYInactiveISONIAZID USP23

DMF 146622000

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982