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Generated: October 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 008578

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NDA 008578 describes DARAPRIM, which is a drug marketed by Vyera Pharms Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the DARAPRIM profile page.

The generic ingredient in DARAPRIM is pyrimethamine. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pyrimethamine profile page.
Summary for 008578
Applicant:Vyera Pharms Llc
Formulation / Manufacturing:see details
Pharmacology for NDA: 008578
Medical Subject Heading (MeSH) Categories for 008578
Suppliers and Packaging for NDA: 008578
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DARAPRIM pyrimethamine TABLET;ORAL 008578 NDA KAISER FOUNDATION HOSPITALS 0179-0090 0179-0090-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0090-70)
DARAPRIM pyrimethamine TABLET;ORAL 008578 NDA Vyera Pharmaceuticals LLC 69413-330 69413-330-06 6 TABLET in 1 BOTTLE, GLASS (69413-330-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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