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Last Updated: September 26, 2022

Details for New Drug Application (NDA): 040648


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NDA 040648 describes ISONIAZID, which is a drug marketed by Sandoz Inc, Chartwell Rx, Cmp Pharma Inc, Barr, Duramed Pharms Barr, Epic Pharma Llc, Halsey, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lilly, Mikart, Mk Labs, Nexgen Pharma Inc, Panray, Perrigo, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Sun Pharm Industries, Thepharmanetwork Llc, Watson Labs, and Whiteworth Town Plsn, and is included in thirty-four NDAs. It is available from eleven 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. Twelve suppliers are listed for this compound. Additional details are available on the isoniazid profile page.
Summary for 040648
Tradename:ISONIAZID
Applicant:Sandoz Inc
Ingredient:isoniazid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040648
Medical Subject Heading (MeSH) Categories for 040648
Suppliers and Packaging for NDA: 040648
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISONIAZID isoniazid INJECTABLE;INJECTION 040648 ANDA Sandoz Inc 0781-3056 0781-3056-70 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3056-70) > 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Jul 5, 2005TE:RLD:No

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