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Generated: May 26, 2017

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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 NDA: 201699


Pharmacology for NDA: 201699


Suppliers and Packaging for NDA: 201699

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 201699 NDA Merck Sharp & Dohme Corp. 52015-080 52015-080-01 1 BOTTLE in 1 CARTON (52015-080-01) > 20 TABLET, FILM COATED in 1 BOTTLE
TABLET;ORAL 201699 NDA Avera McKennan Hospital 69189-0083 69189-0083-1 1 TABLET, FILM COATED in 1 DOSE PACK (69189-0083-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 27, 2011TE:RLD:Yes
Patent:7,378,508Patent Expiration:Jul 31, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:7,863,249Patent Expiration:Jul 31, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:8,586,551Patent Expiration:Jul 15, 2023Product Flag?YSubstance Flag?YDelist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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