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Generated: November 15, 2018

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Details for New Drug Application (NDA): 021799

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NDA 021799 describes QUALAQUIN, which is a drug marketed by Sun Pharm Industries and is included in one NDA. It is available from three suppliers. Additional details are available on the QUALAQUIN profile page.

The generic ingredient in QUALAQUIN is quinine sulfate. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the quinine sulfate profile page.
Summary for 021799
Tradename:QUALAQUIN
Applicant:Sun Pharm Industries
Ingredient:quinine sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021799
Medical Subject Heading (MeSH) Categories for 021799
Suppliers and Packaging for NDA: 021799
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUALAQUIN quinine sulfate CAPSULE;ORAL 021799 NDA AR Scientific Inc. 13310-153 13310-153-01 100 CAPSULE in 1 BOTTLE, PLASTIC (13310-153-01)
QUALAQUIN quinine sulfate CAPSULE;ORAL 021799 NDA AR Scientific Inc. 13310-153 13310-153-05 500 CAPSULE in 1 BOTTLE, PLASTIC (13310-153-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength324MG
Approval Date:Aug 12, 2005TE:ABRLD:Yes

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