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Generated: July 21, 2017

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Details for New Drug Application (NDA): 086151

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NDA 086151 describes PHENYLBUTAZONE, which is a drug marketed by Ivax Pharms, Sandoz, Watson Labs, and Sun Pharm Inds, and is included in eight NDAs. Additional details are available on the PHENYLBUTAZONE profile page.

The generic ingredient in PHENYLBUTAZONE is phenylbutazone. There are nine drug master file entries for this compound. Additional details are available on the phenylbutazone profile page.

Summary for NDA: 086151

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Boehringer Ingelheim
Dow
QuintilesIMS
Citi
Julphar
McKinsey
UBS
McKesson
Baxter

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