Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022437
Company: VERITY
Company: VERITY
| 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 |
|---|---|---|---|---|---|
| 04/12/2024 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020715s049,021288s044,022437s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020715Orig1s049; 021288Orig1s044; 022437Orig1s024ltr.pdf | |
| 11/17/2023 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020715s047,021288s042,022437s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020715Orig1s047; 021288Orig1s042; 022437Orig1s022ltr.pdf | |
| 03/03/2023 | SUPPL-20 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020715s045,021288s040,022437s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020715Orig1s045;021288Orig1s040;022437Orig1s020ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 04/12/2024 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020715s049,021288s044,022437s024lbl.pdf | |
| 11/17/2023 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020715s047,021288s042,022437s022lbl.pdf | |
| 03/03/2023 | SUPPL-20 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020715s045,021288s040,022437s020lbl.pdf | |
| 03/03/2023 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020715s045,021288s040,022437s020lbl.pdf | |
| 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 |