Details for New Drug Application (NDA): 017560

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NDA 017560 describes BACTRIM PEDIATRIC, which is a drug marketed by Sun Pharm Industries and is included in one NDA. Additional details are available on the BACTRIM PEDIATRIC profile page.

The generic ingredient in BACTRIM PEDIATRIC 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 017560

Tradename:	BACTRIM PEDIATRIC
Applicant:	Sun Pharm Industries
Ingredient:	sulfamethoxazole; trimethoprim
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	No

Expired US Patents for NDA 017560

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Sun Pharm Industries	BACTRIM PEDIATRIC	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-002	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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