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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021799
Company: SUN PHARM INDUSTRIES

Medication Guide

Products on NDA 021799

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QUALAQUIN	QUININE SULFATE	324MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021799

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
06/19/2019	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021799s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021799Orig1s029ltr.pdf
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

Labels for NDA 021799

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/19/2019	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021799s029lbl.pdf
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

Therapeutic Equivalents for NDA 021799

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 INDUSTRIES
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	204372	NOVAST LABS
QUININE SULFATE	QUININE SULFATE	324MG	CAPSULE;ORAL	Prescription	No	AB	091661	TEVA PHARMS

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