Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021731
Company: TOLMAR THERAP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELIGARD LEUPROLIDE ACETATE 45MG/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
12/14/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021731s000_EligardTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/15/2019 SUPPL-37 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-29 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-27 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
07/18/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/27/2013 SUPPL-23 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
04/03/2013 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/08/2011 SUPPL-13 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-12 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-10 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-5 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
09/29/2006 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021731s004LTR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/15/2019 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021343s039,021379s041,021488s036,021731s037lbl.pdf
02/29/2016 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf
10/10/2014 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021343s030,021379s030,021488s027,021731s027lbl.pdf
02/27/2013 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf
04/08/2011 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf
01/14/2011 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf
10/05/2010 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf
11/08/2007 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf

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