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Serving leading biopharmaceutical companies globally:

Julphar
Merck
QuintilesIMS
Argus Health
Moodys
Covington
Cantor Fitzgerald
Cerilliant
Citi
Colorcon

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203924

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NDA 203924 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 203924
Tradename:PRIMAQUINE PHOSPHATE
Applicant:Alvogen Inc
Ingredient:primaquine phosphate
Patents:0
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Pharmacology for NDA: 203924
Medical Subject Heading (MeSH) Categories for 203924
Suppliers and Packaging for NDA: 203924
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIMAQUINE PHOSPHATE primaquine phosphate TABLET;ORAL 203924 ANDA Alvogen, Inc. 47781-331 47781-331-30 30 TABLET, FILM COATED in 1 BOTTLE (47781-331-30)
PRIMAQUINE PHOSPHATE primaquine phosphate TABLET;ORAL 203924 ANDA Alvogen, Inc. 47781-331 47781-331-10 1000 TABLET, FILM COATED in 1 BOTTLE (47781-331-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Feb 3, 2014TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Federal Trade Commission
Julphar
Novartis
Colorcon
Cantor Fitzgerald
Argus Health
Fuji
Boehringer Ingelheim

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