Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022291
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMACTA ELTROMBOPAG OLAMINE EQ 25MG ACID TABLET;ORAL Prescription None Yes No
PROMACTA ELTROMBOPAG OLAMINE EQ 50MG ACID TABLET;ORAL Prescription None Yes No
PROMACTA ELTROMBOPAG OLAMINE EQ 75MG ACID TABLET;ORAL Prescription None Yes Yes
PROMACTA ELTROMBOPAG OLAMINE EQ 12.5MG ACID TABLET;ORAL Prescription None Yes No
PROMACTA ELTROMBOPAG OLAMINE EQ 100MG ACID TABLET;ORAL Prescription None 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
11/20/2008 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022291lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022291s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022291s000_TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022291s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/05/2017 SUPPL-18 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s018lbl.pdf
03/09/2017 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022291Orig1s017,207027Orig1s002ltr.pdf
10/12/2016 SUPPL-16 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022291s016,207027s001lbl.pdf
06/11/2015 SUPPL-15 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022291s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022291Orig1s015ltr.pdf
04/07/2015 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022291s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022291Orig1s014ltr.pdf
07/16/2014 SUPPL-13 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s013ltr.pdf
08/26/2014 SUPPL-12 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s012ltr.pdf
04/10/2014 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s011ltr.pdf
02/10/2014 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022291Orig1s010ltr.pdf
11/16/2012 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022291s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022291Orig1s008ltr.pdf
12/06/2011 SUPPL-6 Labeling, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022291s006ltr.pdf
03/05/2010 SUPPL-3 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022291s003ltr.pdf
02/25/2011 SUPPL-1 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022291s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/05/2017 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s018lbl.pdf
03/09/2017 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s017lbl.pdf
10/12/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022291s016,207027s001lbl.pdf
06/11/2015 SUPPL-15 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022291s015lbl.pdf
04/07/2015 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022291s014lbl.pdf
08/26/2014 SUPPL-12 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s012lbl.pdf
04/10/2014 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291Orig1s011lbl.pdf
02/10/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s010lbl.pdf
02/10/2014 SUPPL-10 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s010lbl.pdf
11/16/2012 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022291s008lbl.pdf
12/06/2011 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s006lbl.pdf
12/06/2011 SUPPL-6 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s006lbl.pdf
02/25/2011 SUPPL-1 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s001lbl.pdf
11/20/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022291lbl.pdf

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