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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Express Scripts
Fish and Richardson

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206043

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NDA 206043 describes PRIMAQUINE PHOSPHATE, which is a drug marketed by Alvogen Inc, Bayshore Pharms Llc, and Ingenus Pharms Nj, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the PRIMAQUINE PHOSPHATE profile page.

The generic ingredient in PRIMAQUINE PHOSPHATE is primaquine phosphate. There are four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the primaquine phosphate profile page.
Summary for 206043
Applicant:Ingenus Pharms Nj
Ingredient:primaquine phosphate
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Pharmacology for NDA: 206043
Medical Subject Heading (MeSH) Categories for 206043
Suppliers and Packaging for NDA: 206043
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIMAQUINE PHOSPHATE primaquine phosphate TABLET;ORAL 206043 ANDA Ingenus Pharmaceuticals, LLC 50742-191 N 50742-191-05
PRIMAQUINE PHOSPHATE primaquine phosphate TABLET;ORAL 206043 ANDA Ingenus Pharmaceuticals, LLC 50742-191 N 50742-191-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Jun 23, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Daiichi Sankyo

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