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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 090624


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NDA 090624 describes SULFAMETHOXAZOLE AND TRIMETHOPRIM, which is a drug marketed by Abraxis Pharm, Bedford, Hikma, Hospira, Mylan Labs Ltd, Somerset, Teva Pharms Usa, Watson Labs, Ani Pharms, Aurobindo Pharma, Chartwell Molecular, Lupin Ltd, Novitium Pharma, Prasco, Teva, Amneal Pharms Ny, Chartwell Molecules, Fosun Pharma, Glenmark Pharms Ltd, Heather, Interpharm, Martec Usa Llc, Mutual Pharm, Pliva, Roxane, Sun Pharm Industries, Usl Pharma, Vista Pharms, Able, and Heritage Pharma Avet, and is included in forty-seven NDAs. It is available from forty-five 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 090624
Suppliers and Packaging for NDA: 090624
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim TABLET;ORAL 090624 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8121 0615-8121-10 10 TABLET in 1 BLISTER PACK (0615-8121-10)
SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim TABLET;ORAL 090624 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8121 0615-8121-14 14 TABLET in 1 BLISTER PACK (0615-8121-14)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG;80MG
Approval Date:Feb 16, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG;160MG
Approval Date:Feb 16, 2010TE:ABRLD:No

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