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New Drug Application (NDA): 020500
Company: GLAXOSMITHKLINE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEPRON ATOVAQUONE 750MG/5ML SUSPENSION;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
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.

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

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 INC
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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