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Serving leading biopharmaceutical companies globally:

Express Scripts
Moodys
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Fuji
Medtronic
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Healthtrust
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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080937

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NDA 080937 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 080937
Tradename:ISONIAZID
Applicant:Barr
Ingredient:isoniazid
Patents:0
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 080937
Medical Subject Heading (MeSH) Categories for 080937
Suppliers and Packaging for NDA: 080937
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISONIAZID isoniazid TABLET;ORAL 080937 ANDA Liberty Pharmaceuticals, Inc. 0440-1655 0440-1655-30 30 TABLET in 1 BOTTLE, PLASTIC (0440-1655-30)
ISONIAZID isoniazid TABLET;ORAL 080937 ANDA Teva Pharmaceuticals USA, Inc. 0555-0071 0555-0071-02 100 TABLET in 1 BOTTLE (0555-0071-02)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Cerilliant
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Federal Trade Commission
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Johnson and Johnson
Cantor Fitzgerald
Fuji

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