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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080212

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NDA 080212 describes ISONIAZID, which is a drug marketed by Sandoz Inc, Cmp Pharma Inc, Mikart, 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 twenty-six 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the isoniazid profile page.

Summary for 080212

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 080212

Medical Subject Heading (MeSH) Categories for 080212

Suppliers and Packaging for NDA: 080212

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISONIAZID isoniazid TABLET;ORAL 080212 ANDA West-Ward Pharmaceuticals Corp 0143-1260 0143-1260-01 100 TABLET in 1 BOTTLE (0143-1260-01)
ISONIAZID isoniazid TABLET;ORAL 080212 ANDA West-Ward Pharmaceuticals Corp 0143-1260 0143-1260-10 1000 TABLET in 1 BOTTLE (0143-1260-10)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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