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-eight 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:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	80MG/ML;16MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 018374

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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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