Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021799
Company: SUN PHARM INDS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUALAQUIN QUININE SULFATE 324MG CAPSULE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/12/2005 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021799lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021799ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021799s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/02/2014 SUPPL-24 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021799s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021799Orig1s024ltr.pdf
04/13/2013 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021799s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021799Orig1s023ltr.pdf
05/22/2012 SUPPL-22 Labeling-Medication Guide, REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021799s022ltr.pdf
02/22/2013 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021799s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021799Orig1s021ltr.pdf
05/22/2012 SUPPL-20 REMS-Assessment

Label is not available on this site.

04/14/2011 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021799s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021799s016ltr.pdf
01/22/2010 SUPPL-15 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021799s015ltr.pdf
11/20/2009 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021799s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021799s014ltr.pdf
12/23/2009 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021799s013ltr.pdf
06/15/2010 SUPPL-11 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021799s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021799s011ltr.pdf
11/14/2008 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021799s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021799s008ltr.pdf
10/03/2007 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021799s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021799s006ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/02/2014 SUPPL-24 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021799s024lbl.pdf
04/13/2013 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021799s023lbl.pdf
02/22/2013 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021799s021lbl.pdf
04/14/2011 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021799s016lbl.pdf
06/15/2010 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021799s011lbl.pdf
06/15/2010 SUPPL-11 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021799s011lbl.pdf
11/20/2009 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021799s014lbl.pdf
11/14/2008 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021799s008lbl.pdf
10/03/2007 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021799s006lbl.pdf
08/12/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021799lbl.pdf

QUALAQUIN

CAPSULE;ORAL; 324MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
QUALAQUIN QUININE SULFATE 324MG CAPSULE;ORAL Prescription Yes AB 021799 SUN PHARM INDS
QUININE SULFATE QUININE SULFATE 324MG CAPSULE;ORAL Prescription No AB 203729 AMNEAL PHARMS
QUININE SULFATE QUININE SULFATE 324MG CAPSULE;ORAL Prescription No AB 203112 LUPIN LTD
QUININE SULFATE QUININE SULFATE 324MG CAPSULE;ORAL Prescription No AB 202581 MYLAN PHARMS INC
QUININE SULFATE QUININE SULFATE 324MG CAPSULE;ORAL Prescription No AB 204372 RICONPHARMA LLC
QUININE SULFATE QUININE SULFATE 324MG CAPSULE;ORAL Prescription No AB 091661 TEVA PHARMS

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