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Generated: November 13, 2018

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Details for New Drug Application (NDA): 009768

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NDA 009768 describes PLAQUENIL, which is a drug marketed by Concordia Pharms Inc and is included in one NDA. It is available from six suppliers. Additional details are available on the PLAQUENIL profile page.

The generic ingredient in PLAQUENIL is hydroxychloroquine sulfate. There are fifteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.
Summary for 009768
Tradename:PLAQUENIL
Applicant:Concordia Pharms Inc
Ingredient:hydroxychloroquine sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 009768
Medical Subject Heading (MeSH) Categories for 009768
Suppliers and Packaging for NDA: 009768
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AvKARE, Inc. 42291-335 42291-335-90 90 TABLET in 1 BOTTLE (42291-335-90)
PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768 NDA AUTHORIZED GENERIC Aphena Pharma Solutions - Tennessee, LLC 43353-051 43353-051-09 9000 TABLET in 1 BOTTLE (43353-051-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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