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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 008678


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NDA 008678 describes ISONIAZID, which is a drug marketed by Sandoz Inc, Anda Repository, Cmp Pharma Inc, Barr, Duramed Pharms Barr, Halsey, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lilly, Mk Labs, Nexgen Pharma Inc, Panray, Perrigo, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Sandoz, Sun Pharm Industries, Thepharmanetwork Llc, Watson Labs, and Whiteworth Town Plsn, and is included in thirty-four NDAs. It is available from twelve suppliers. Additional details are available on the ISONIAZID profile page.

The generic ingredient in ISONIAZID is isoniazid. There are five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the isoniazid profile page.
Summary for 008678
Tradename:ISONIAZID
Applicant:Sandoz
Ingredient:isoniazid
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 008678

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
McKinsey
Boehringer Ingelheim
Harvard Business School
Baxter

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