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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077612

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NDA 077612 describes SULFAMETHOXAZOLE AND TRIMETHOPRIM, which is a drug marketed by Abraxis Pharm, Bedford, Hospira, Mylan Labs Ltd, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, Ani Pharms Inc, Aurobindo Pharma, Hi Tech Pharma, Teva, Vintage, Amneal Pharms Ny, Chartwell Molecules, Glenmark Generics, Heather, Interpharm, Martec Usa Llc, Mutual Pharm, Pliva, Roxane, Sandoz, Sun Pharm Industries, Usl Pharma, Vista Pharms, Able, and Teva Pharms, and is included in forty-four NDAs. It is available from sixty-three suppliers. Additional details are available on the SULFAMETHOXAZOLE AND TRIMETHOPRIM profile page.

The generic ingredient in SULFAMETHOXAZOLE AND TRIMETHOPRIM is phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim. There are eight drug master file entries for this compound. Additional details are available on the phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim profile page.

Summary for 077612

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

Suppliers and Packaging for NDA: 077612

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim SUSPENSION;ORAL 077612 ANDA Pharmaceutical Associates, Inc. 0121-4793 0121-4793-20 4 TRAY in 1 CASE (0121-4793-20) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION;ORALStrength200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 13, 2006TE:RLD:No


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Boehringer Ingelheim
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Fuji
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McKesson
Medtronic
Julphar

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