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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050783

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NDA 050783 describes PERIOSTAT, which is a drug marketed by Collagenex and Galderma Labs Lp and is included in two NDAs. Additional details are available on the PERIOSTAT profile page.

The generic ingredient in PERIOSTAT is doxycycline hyclate. There are twenty-seven drug master file entries for this compound. Ninety-five suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 050783
Tradename:PERIOSTAT
Applicant:Galderma Labs Lp
Ingredient:doxycycline hyclate
Patents:0
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 2, 2001TE:RLD:Yes

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