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Generated: October 23, 2018

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Details for New Drug Application (NDA): 086553

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NDA 086553 describes X-TROZINE, which is a drug marketed by Shire Richwood and is included in seven NDAs. Additional details are available on the X-TROZINE profile page.

The generic ingredient in X-TROZINE is phendimetrazine tartrate. There are five drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the phendimetrazine tartrate profile page.
Summary for 086553
Tradename:X-TROZINE
Applicant:Shire Richwood
Ingredient:phendimetrazine tartrate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength35MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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