Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022505
Company: THERATECHNOLOGIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EGRIFTA TESAMORELIN ACETATE EQ 1MG BASE/VIAL POWDER;SUBCUTANEOUS Prescription None Yes Yes
EGRIFTA TESAMORELIN ACETATE EQ 2MG BASE/VIAL POWDER;SUBCUTANEOUS 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
11/10/2010 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/2010/022505s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022505s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022505Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022505Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/05/2019 SUPPL-13 Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022505Orig1s012, s013ltr.pdf
07/05/2019 SUPPL-12 Labeling-Package Insert, Labeling-Proprietary Name Change, Labeling-Container/Carton Labels, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022505Orig1s012, s013ltr.pdf
01/18/2019 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022505Orig1s011ltr.pdf
SUPPL-10 Manufacturing (CMC)-Formulation Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505Orig1s010lbl.pdf
06/08/2015 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022505s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022505Orig1s007ltr.pdf
02/09/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/15/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/07/2013 SUPPL-4 Labeling-Medication Guide Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022505s004lbl.pdf
11/29/2011 SUPPL-3 Labeling-Patient Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf
11/29/2011 SUPPL-1 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/05/2019 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
07/05/2019 SUPPL-13 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
07/05/2019 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
07/05/2019 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
07/05/2019 SUPPL-12 Labeling-Proprietary Name Change Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
07/05/2019 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
07/05/2019 SUPPL-12 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf
01/18/2019 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s011lbl.pdf
06/08/2015 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022505s007lbl.pdf
01/07/2013 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022505s004lbl.pdf
11/29/2011 SUPPL-3 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf
11/29/2011 SUPPL-1 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf
11/10/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022505s000lbl.pdf
SUPPL-10 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505Orig1s010lbl.pdf

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