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Generated: November 22, 2018

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Details for New Drug Application (NDA): 018714

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NDA 018714 describes BILTRICIDE, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from two suppliers. Additional details are available on the BILTRICIDE profile page.

The generic ingredient in BILTRICIDE is praziquantel. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the praziquantel profile page.
Summary for 018714
Tradename:BILTRICIDE
Applicant:Bayer Hlthcare
Ingredient:praziquantel
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018714
Medical Subject Heading (MeSH) Categories for 018714
Suppliers and Packaging for NDA: 018714
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BILTRICIDE praziquantel TABLET;ORAL 018714 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-747 50419-747-01 6 TABLET, FILM COATED in 1 BOTTLE (50419-747-01)
BILTRICIDE praziquantel TABLET;ORAL 018714 NDA Central Texas Community Health Centers 76413-146 76413-146-01 1 TABLET, FILM COATED in 1 BOTTLE (76413-146-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Dec 29, 1982TE:ABRLD:Yes

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