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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 018374


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NDA 018374 describes BACTRIM, which is a drug marketed by Sun Pharm Inds Inc and Sun Pharm Industries and is included in three NDAs. It is available from two suppliers. Additional details are available on the BACTRIM profile page.

The generic ingredient in BACTRIM is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.
Summary for 018374
Tradename:BACTRIM
Applicant:Sun Pharm Inds Inc
Ingredient:sulfamethoxazole; trimethoprim
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength80MG/ML;16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 018374

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sun Pharm Inds Inc BACTRIM sulfamethoxazole; trimethoprim INJECTABLE;INJECTION 018374-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Inc BACTRIM sulfamethoxazole; trimethoprim INJECTABLE;INJECTION 018374-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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