Details for New Drug Application (NDA): 017377

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NDA 017377 describes BACTRIM DS, which is a drug marketed by Sun Pharm Industries and is included in one NDA. It is available from two suppliers. Additional details are available on the BACTRIM DS profile page.

The generic ingredient in BACTRIM 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 017377

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

Pharmacology for NDA: 017377

Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 2C9 Inhibitors Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors

Suppliers and Packaging for NDA: 017377

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BACTRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377	NDA	Sun Pharmaceutical Industries, Inc	49708-145	49708-145-01	100 TABLET in 1 BOTTLE, PLASTIC (49708-145-01)
BACTRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377	NDA	Sun Pharmaceutical Industries, Inc	49708-146	49708-146-01	100 TABLET in 1 BOTTLE, PLASTIC (49708-146-01)

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:	Yes

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:	Yes

Expired US Patents for NDA 017377

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Sun Pharm Industries	BACTRIM DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-002	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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