Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204683
Company: OSMOTICA PHARM CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KHEDEZLA DESVENLAFAXINE 50MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
KHEDEZLA DESVENLAFAXINE 100MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No 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
07/10/2013 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/2013/204683s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204683Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204683Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204683Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/29/2019 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204683s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204683Orig1s006ltr.pdf
12/19/2017 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204683Orig1s005,022104Orig1s016ltr.pdf
01/04/2017 SUPPL-4 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204683Orig1s004ltr.pdf
09/06/2016 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204683s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204683Orig1s003ltr.pdf
07/16/2014 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204683s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204683Orig1s002ltr.pdf
10/01/2013 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204683s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204683Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/29/2019 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204683s006lbl.pdf
12/19/2017 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s005lbl.pdf
01/04/2017 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s004lbl.pdf
01/04/2017 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s004lbl.pdf
09/06/2016 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204683s003lbl.pdf
07/16/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204683s002lbl.pdf
07/16/2014 SUPPL-2 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204683s002lbl.pdf
10/01/2013 SUPPL-1 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204683s001lbl.pdf
10/01/2013 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204683s001lbl.pdf
07/10/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204683s000lbl.pdf

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