Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022437
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRELSTAR TRIPTORELIN PAMOATE EQ 22.5MG BASE/VIAL INJECTABLE;INTRAMUSCULAR 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
03/10/2010 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022437lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022437s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022437_trelstar_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022437Orig1s000sumr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/14/2018 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020715s040,021288s035,022427s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020715Orig1s040,%20021288Orig1s035,%20022437Orig1s015ltr.pdf
01/26/2015 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/20/2015 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/03/2014 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/11/2014 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020715s032,021288s028,022437s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020715Orig1s032,021288Orig1s028,022437Orig1s008ltr.pdf
03/12/2013 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020715s030,021288s027,022437s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020715Orig1s030,021288Orig1s027,022437Orig1s007ltr.pdf
04/19/2013 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/11/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/25/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/19/2011 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s025,021288s022,022437s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020715s025,021288s022,022437s003ltr.pdf
01/14/2011 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s024,021288s021,022437s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020715s024,021288s021,022437s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/14/2018 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020715s040,021288s035,022427s015lbl.pdf
07/11/2014 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020715s032,021288s028,022437s008lbl.pdf
03/12/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020715s030,021288s027,022437s007lbl.pdf
05/19/2011 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s025,021288s022,022437s003lbl.pdf
01/14/2011 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s024,021288s021,022437s002lbl.pdf
03/10/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022437lbl.pdf

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