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Details for New Drug Application (NDA): 201699

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NDA 201699 describes DIFICID, which is a drug marketed by Cubist Pharms Llc and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DIFICID profile page.

The generic ingredient in DIFICID is fidaxomicin. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fidaxomicin profile page.

Summary for 201699

Tradename:	DIFICID
Applicant:	Cubist Pharms Llc
Ingredient:	fidaxomicin
Patents:	5

Pharmacology for NDA: 201699

Ingredient-type

Macrolides

Suppliers and Packaging for NDA: 201699

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIFICID	fidaxomicin	TABLET;ORAL	201699	NDA	Merck Sharp & Dohme Corp.	52015-080	N	52015-080-01
DIFICID	fidaxomicin	TABLET;ORAL	201699	NDA	Avera McKennan Hospital	69189-0083	N	69189-0083-1

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	May 27, 2011	TE:		RLD:	Yes
Patent:		Patent Expiration:	Jul 31, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:		Patent Expiration:	Jul 31, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:		Patent Expiration:	Mar 4, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF MICROBIAL INFECTIONS

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