Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022256
Company: ALLERGAN SALES LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SAVELLA MILNACIPRAN HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription None Yes No
SAVELLA MILNACIPRAN HYDROCHLORIDE 25MG TABLET;ORAL Prescription None Yes No
SAVELLA MILNACIPRAN HYDROCHLORIDE 50MG TABLET;ORAL Prescription None Yes Yes
SAVELLA MILNACIPRAN HYDROCHLORIDE 100MG TABLET;ORAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/14/2009 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022256lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022256ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022256s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2009/022256s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2017 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022256s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022256Orig1s023ltr.pdf
12/30/2016 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022256s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022256Orig1s022ltr.pdf
09/06/2016 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022256s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022256Orig1s021ltr.pdf
06/17/2015 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/29/2015 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022256s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022256Orig1s019ltr.pdf
05/21/2015 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/25/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/25/2013 SUPPL-16 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s016lbl.pdf
10/30/2013 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022256Orig1s014,s015ltr.pdf
10/30/2013 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022256Orig1s014,s015ltr.pdf
12/06/2012 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022256s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022256Orig1s013ltr.pdf
10/30/2012 SUPPL-12 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022256Orig1s012ltr.pdf
11/08/2011 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022256s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022256s011ltr.pdf
04/26/2011 SUPPL-10 REMS-Modified, REMS-Assessment Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022256s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022256Orig1s010.pdf
05/17/2010 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022256s006ltr.pdf
06/01/2010 SUPPL-5 Labeling-Container/Carton Labels

Label is not available on this site.

02/02/2010 SUPPL-4 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022256s004ltr.pdf
02/01/2010 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022256s002ltr.pdf
04/16/2009 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022256s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022256s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/19/2017 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022256s023lbl.pdf
12/30/2016 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022256s022lbl.pdf
09/06/2016 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022256s021lbl.pdf
01/29/2015 SUPPL-19 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022256s019lbl.pdf
01/29/2015 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022256s019lbl.pdf
10/30/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s014s015lbl.pdf
10/30/2013 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s014s015lbl.pdf
06/25/2013 SUPPL-16 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022256s016lbl.pdf
12/06/2012 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022256s013lbl.pdf
11/08/2011 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022256s011lbl.pdf
05/17/2010 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s006lbl.pdf
02/02/2010 SUPPL-4 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s004lbl.pdf
02/01/2010 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022256s002lbl.pdf
04/16/2009 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022256s001lbl.pdf
04/16/2009 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022256s001lbl.pdf
01/14/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022256lbl.pdf

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