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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 one supplier. 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. One supplier is listed for this compound. Additional details are available on the praziquantel profile page.

Summary for NDA: 018714

Bayer Hlthcare
Therapeutic Class:Antiparasitics

Pharmacology for NDA: 018714

Suppliers and Packaging for NDA: 018714

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 018714 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-747 50419-747-01 6 TABLET, FILM COATED in 1 BOTTLE (50419-747-01)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 018714

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
TABLET;ORAL018714-001Dec 29, 19824,001,411► subscribe
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