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Details for New Drug Application (NDA): 072383

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NDA 072383 describes SULFAMETHOXAZOLE AND TRIMETHOPRIM, which is a drug marketed by Interpharm, Watson Labs, Teva Pharms Usa, Usl Pharma, Mutual Pharm, Martec Usa Llc, Ani Pharms Inc, Teva, Pliva, Sun Pharm Inds, Vista Pharms, Abraxis Pharm, Aurobindo Pharma, West-ward Pharms Int, Glenmark Generics, Heather, Hi Tech Pharma, Vintage, Roxane, Bedford, Sandoz, Hospira, Amneal Pharms Ny, 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 NDA: 072383

Tradename:
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Applicant:
Bedford
Ingredient:
sulfamethoxazole; trimethoprim
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength80MG/ML;16MG/ML
Approval Date:Apr 29, 1992TE: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.

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