Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021379
Company: TOLMAR THERAP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELIGARD LEUPROLIDE ACETATE 22.5MG/VIAL INJECTABLE;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
07/24/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21379lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21379ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-379_Eligard.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/15/2019 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021343s039,021379s041,021488s036,021731s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021343Orig1s039,021731Orig1s037,021488Orig1s036,021379Orig1s041ltr.pdf
02/29/2016 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021343Orig1s033,021379Orig1s033,021488Orig1s030,021731Orig1s029ltr.pdf
10/10/2014 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021343Orig1s030,021379Orig1s030,021488Orig1s027,021731Orig1s027ltr.pdf
04/15/2014 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/03/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

07/18/2014 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/27/2013 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021343Orig1s027,021379Orig1s025,021488Orig1s025,021731Orig1s023ltr.pdf
02/08/2013 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/25/2013 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/08/2011 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s020,021379s016,021488s017,021731s013ltr.pdf
01/14/2011 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021343s019,021379s015,021488s016,021731s012ltr.pdf
10/05/2010 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021343s018,021379s014,021488s015,021731s010ltr.pdf
11/08/2007 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021343s015, 021488s010, 021379s010, 021731s005ltr.pdf
01/12/2004 SUPPL-2 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21343slr004,21379slr002,21488slr002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021379_s002_ELIGARD.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/15/2019 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021343s039,021379s041,021488s036,021731s037lbl.pdf
02/29/2016 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf
10/10/2014 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf
02/27/2013 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf
04/08/2011 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf
01/14/2011 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf
10/05/2010 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf
11/08/2007 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf
07/24/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21379lbl.pdf

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