Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020715
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRELSTAR TRIPTORELIN PAMOATE EQ 3.75MG 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
06/15/2000 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20715lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20715ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-715_Trelstar.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/14/2018 SUPPL-40 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, 021288Orig1s035, 022437Orig1s015ltr.pdf
02/03/2015 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

07/15/2014 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/11/2014 SUPPL-32 Labeling-Container/Carton Labels 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
03/14/2014 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/12/2013 SUPPL-30 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
06/19/2013 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/11/2013 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/25/2013 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/19/2011 SUPPL-25 Labeling-Package Insert 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-24 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
03/16/2010 SUPPL-18 Labeling

Label is not available on this site.

04/14/2008 SUPPL-16 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020715s016, 021288s013ltr.pdf
02/16/2007 SUPPL-13 Labeling-Container/Carton Labels

Label is not available on this site.

10/20/2005 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021288s002,020715s006ltr.pdf
01/15/2002 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20715s3ltr.pdf
01/15/2002 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20715s3ltr.pdf
06/20/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/14/2018 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020715s040,021288s035,022427s015lbl.pdf
07/11/2014 SUPPL-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020715s032,021288s028,022437s008lbl.pdf
03/12/2013 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020715s030,021288s027,022437s007lbl.pdf
05/19/2011 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s025,021288s022,022437s003lbl.pdf
01/14/2011 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s024,021288s021,022437s002lbl.pdf
06/15/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20715lbl.pdf

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