Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204150
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESVENLAFAXINE DESVENLAFAXINE 50MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
DESVENLAFAXINE DESVENLAFAXINE 100MG TABLET, EXTENDED RELEASE;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
03/04/2013 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Letter (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204150s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204150Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204150Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204150Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204150_desvenlafaxine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204150Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/29/2019 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204150s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204150Orig1s010ltr.pdf
12/19/2017 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204150s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204150Orig1s007ltr.pdf
01/04/2017 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204150s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204150Orig1s005ltr.pdf
09/09/2016 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204150s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204150Orig1s004ltr.pdf
05/15/2015 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204150s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204150Orig1s003ltr.pdf
07/07/2014 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204150s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204150Orig1s001,s002ltr.pdf
07/07/2014 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204150s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204150Orig1s001,s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/29/2019 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204150s010lbl.pdf
12/19/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204150s007lbl.pdf
01/04/2017 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204150s005lbl.pdf
09/09/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204150s004lbl.pdf
05/15/2015 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204150s003lbl.pdf
05/15/2015 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204150s003lbl.pdf
07/07/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204150s001s002lbl.pdf
07/07/2014 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204150s001s002lbl.pdf
03/04/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204150s000lbl.pdf

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