Details for New Drug Application (NDA): 017376

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NDA 017376 describes SEPTRA DS, which is a drug marketed by Monarch Pharms and is included in one NDA. Additional details are available on the SEPTRA DS profile page.

The generic ingredient in SEPTRA DS 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 017376

Tradename:	SEPTRA DS
Applicant:	Monarch Pharms
Ingredient:	sulfamethoxazole; trimethoprim
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG;80MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG;160MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	No

Expired US Patents for NDA 017376

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Monarch Pharms	SEPTRA	sulfamethoxazole; trimethoprim	TABLET;ORAL	017376-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Monarch Pharms	SEPTRA DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017376-002	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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