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Federal Trade Commission
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Dow
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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091348

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NDA 091348 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, Fosun Pharma, Glenmark Generics, Heather, Interpharm, Martec Usa Llc, Mutual Pharm, Pliva, Roxane, Sun Pharm Industries, Usl Pharma, Vista Pharms, Able, and Teva Pharms, and is included in forty-four NDAs. It is available from sixty-four 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 091348
Tradename:SULFAMETHOXAZOLE AND TRIMETHOPRIM
Applicant:Aurobindo Pharma
Ingredient:sulfamethoxazole; trimethoprim
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 091348
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim SUSPENSION;ORAL 091348 ANDA ATLANTIC BIOLOGICALS CORP. 17856-0496 N 17856-0496-1
SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim SUSPENSION;ORAL 091348 ANDA ATLANTIC BIOLOGICALS CORP. 17856-0496 N 17856-0496-2

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength200MG/5ML;40MG/5ML
Approval Date:Jun 8, 2010TE:ABRLD:No

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