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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020500
Company: GLAXOSMITHKLINE LLC

Products on NDA 020500

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEPRON	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020500

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/08/1995	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2019	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020500s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020500Orig1s019ltr.pdf
02/22/2019	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020500s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020500Orig1s017ltr.pdf
10/15/2017	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20500s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020500Orig1s016ltr.pdf
06/04/2015	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020500s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020500Orig1s015ltr.pdf
03/01/2013	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020500s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020500Orig1s014ltr.pdf
05/07/2008	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020500s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020500s010ltr.pdf
01/05/1999	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20-500-S005.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20500s5ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020500S005.cfm
09/14/1998	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/12/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/02/1997	SUPPL-2	Labeling		Label is not available on this site.
04/28/1995	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020500

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2019	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020500s019lbl.pdf
02/22/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020500s017lbl.pdf
10/15/2017	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20500s016lbl.pdf
10/15/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20500s016lbl.pdf
06/04/2015	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020500s015lbl.pdf
03/01/2013	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020500s014lbl.pdf
05/07/2008	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020500s010lbl.pdf
01/05/1999	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20-500-S005.PDF

Therapeutic Equivalents for NDA 020500

MEPRON

SUSPENSION;ORAL; 750MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	210510	ABHAI LLC
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	214272	ABON PHARMS LLC
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	202960	AMNEAL PHARMS
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	209750	APOTEX
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	212918	BIONPHARMA
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	207833	CHARTWELL RX
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	209685	GLENMARK PHARMS
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	210692	HETERO LABS LTD III
ATOVAQUONE	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	209105	LUPIN LTD
MEPRON	ATOVAQUONE	750MG/5ML	SUSPENSION;ORAL	Prescription	Yes	AB	020500	GLAXOSMITHKLINE LLC

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