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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

Carolina Medcl
Therapeutic Class:Antimycobacterials

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:Yes

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