Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205583
Company: SUN PHARMA GLOBAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESVENLAFAXINE DESVENLAFAXINE FUMARATE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
DESVENLAFAXINE DESVENLAFAXINE FUMARATE EQ 100MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued 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
01/28/2014 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205583Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205583Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205583Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2017 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205583s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205583Orig1s006ltr.pdf
01/04/2017 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205583s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205583Orig1s005ltr.pdf
02/03/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/18/2014 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205583Orig1s001,s003ltr.pdf
07/18/2014 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205583Orig1s001,s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/19/2017 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205583s006lbl.pdf
01/04/2017 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205583s005lbl.pdf
07/18/2014 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s001s003lbl.pdf
07/18/2014 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s001s003lbl.pdf
01/28/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s000lbl.pdf

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