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Details for New Drug Application (NDA): 088235

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NDA 088235 describes ISONIAZID, which is a drug marketed by Watson Labs, Ivax Sub Teva Pharms, Thepharmanetwork Llc, Hikma Intl Pharms, Mikart, Duramed Pharms Barr, Whiteworth Town Plsn, Panray, Halsey, Purepac Pharm, Sun Pharm Inds, Carolina Medcl, Barr, Mk Labs, Sandoz, Nexgen Pharma Inc, Impax Labs, Perrigo, Phoenix Labs Ny, Pharmavite, and Lilly, and is included in thirty-four NDAs. It is available from twenty-eight 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. Thirty-one suppliers are listed for this compound. Additional details are available on the isoniazid profile page.

Summary for NDA: 088235

Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 088235

Suppliers and Packaging for NDA: 088235

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYRUP;ORAL 088235 ANDA Carolina Medical Products Company 46287-009 46287-009-01 473 mL in 1 BOTTLE (46287-009-01)
SYRUP;ORAL 088235 ANDA A-S Medication Solutions LLC 54569-2900 54569-2900-0 473 mL in 1 BOTTLE (54569-2900-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength50MG/5ML
Approval Date:Nov 10, 1983TE:RLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.