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Details for New Drug Application (NDA): 090828

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NDA 090828 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, Eurohlth Intl Sarl, 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-two 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.

Suppliers and Packaging for NDA: 090828

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sulfamethoxazole; trimethoprim
TABLET;ORAL 090828 ANDA Blenheim Pharmacal, Inc. 10544-092 10544-092-06 6 TABLET in 1 BOTTLE (10544-092-06)
sulfamethoxazole; trimethoprim
TABLET;ORAL 090828 ANDA Blenheim Pharmacal, Inc. 10544-092 10544-092-14 14 TABLET in 1 BOTTLE (10544-092-14)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG;160MG
Approval Date:Dec 22, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG;80MG
Approval Date:Dec 22, 2010TE:ABRLD:No

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