Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021343
Company: TOLMAR
Company: TOLMAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ELIGARD KIT | LEUPROLIDE ACETATE | 7.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/23/2002 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21343lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21343ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-343_Eligard.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/23/2024 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021343s051,021379s053,021488s048,021731s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021343Orig1s051, 021379Orig1s053, 021488Orig1s048, 021731Orig1s051ltr.pdf | |
| 07/20/2023 | SUPPL-48 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021343Orig1s047,s048;021379Orig1s049,s050;021488Orig1s044,s045;021731Orig1s044,s047ltr.pdf | |
| 07/20/2023 | SUPPL-47 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021343Orig1s047,s048;021379Orig1s049,s050;021488Orig1s044,s045;021731Orig1s044,s047ltr.pdf | |
| 02/15/2019 | SUPPL-39 | 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 | |
| 01/13/2017 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/29/2016 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021343Orig1s033.pdf | |
| 10/26/2015 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/2014 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 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 | |
| 05/30/2014 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/2014 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/2013 | SUPPL-27 | 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 | |
| 04/09/2013 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/2011 | SUPPL-20 | 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-19 | 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-18 | 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-15 | 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-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21343slr004,21379slr002,21488slr002ltr.pdf |
| 07/03/2003 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21343slr002ltr.pdf |
| 04/01/2002 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21343s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/23/2024 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021343s051,021379s053,021488s048,021731s051lbl.pdf | |
| 07/20/2023 | SUPPL-48 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf | |
| 07/20/2023 | SUPPL-47 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021343s047s048,021379s049s050,021488s044s045,021731s044s047lbl.pdf | |
| 02/15/2019 | SUPPL-39 | 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-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf | |
| 04/08/2011 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s020,021379s016,021488s017,021731s013lbl.pdf | |
| 01/14/2011 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf | |
| 10/05/2010 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021343s018,021379s014,021488s015,021731s010lbl.pdf | |
| 11/08/2007 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021731s005,021488s010,021379s010,021343s015lbl.pdf | |
| 01/23/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21343lbl.pdf |