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Details for New Drug Application (NDA): 018374

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

The generic ingredient in BACTRIM is sulfamethoxazole; trimethoprim. There are twenty-six drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.

Summary for NDA: 018374

Mutual Pharm
sulfamethoxazole; trimethoprim
Therapeutic Class:Antibacterials

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength80MG/ML;16MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired Orange Book Patents for NDA: 018374

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mutual Pharm
sulfamethoxazole; trimethoprim
INJECTABLE;INJECTION018374-001Approved Prior to Jan 1, 19823,551,564► subscribe
Mutual Pharm
sulfamethoxazole; trimethoprim
INJECTABLE;INJECTION018374-001Approved Prior to Jan 1, 1982RE28636► subscribe
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