Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021897
Company: ALKERMES
Company: ALKERMES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIVITROL | NALTREXONE | 380MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 04/13/2006 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021897lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021897s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021897_toc_Vivitrol.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/30/2022 | SUPPL-57 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021897s057lbl.pdf | |
| 05/06/2021 | SUPPL-55 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021897Orig1s055ltr.pdf |
| 03/04/2021 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021897s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021897Orig1s052ltr.pdf | |
| 05/08/2020 | SUPPL-49 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021897s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021897Orig1s049ltr.pdf | |
| 09/06/2019 | SUPPL-45 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021897s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021897Orig1s045ltr.pdf | |
| 06/07/2019 | SUPPL-44 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/28/2018 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021897s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021897Orig1s042ltr.pdf | |
| 12/12/2016 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/2016 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/2016 | SUPPL-32 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021897Orig1s032ltr.pdf |
| 05/19/2016 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/2016 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/2015 | SUPPL-29 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021897s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021897Orig1s029Ltr.pdf | |
| 01/26/2015 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/2014 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/2014 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/2014 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/2013 | SUPPL-23 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021897Orig1s020,s023ltr.pdf | |
| 03/28/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/2013 | SUPPL-20 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021897Orig1s020,s023ltr.pdf | |
| 10/12/2010 | SUPPL-15 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021897s015ltr.pdf | |
| 03/22/2010 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s005s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021897s005s010ltr.pdf | |
| 08/18/2010 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/22/2010 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s005s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021897s005s010ltr.pdf | |
| 10/26/2007 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021897s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021897s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/30/2022 | SUPPL-57 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021897s057lbl.pdf | |
| 09/30/2022 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021897s057lbl.pdf | |
| 03/04/2021 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021897s052lbl.pdf | |
| 05/08/2020 | SUPPL-49 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021897s049lbl.pdf | |
| 05/08/2020 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021897s049lbl.pdf | |
| 05/08/2020 | SUPPL-49 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021897s049lbl.pdf | |
| 09/06/2019 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021897s045lbl.pdf | |
| 09/06/2019 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021897s045lbl.pdf | |
| 09/06/2019 | SUPPL-45 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021897s045lbl.pdf | |
| 12/28/2018 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021897s042lbl.pdf | |
| 12/08/2015 | SUPPL-29 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021897s029lbl.pdf |
| 07/29/2013 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf | |
| 07/29/2013 | SUPPL-23 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf | |
| 07/29/2013 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf | |
| 07/29/2013 | SUPPL-20 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021897s020s023lbl.pdf | |
| 10/12/2010 | SUPPL-15 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s015lbl.pdf | |
| 03/22/2010 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s005s010lbl.pdf | |
| 03/22/2010 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s005s010lbl.pdf | |
| 10/26/2007 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021897s003lbl.pdf | |
| 04/13/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021897lbl.pdf |
VIVITROL
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR; 380MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VIVITROL | NALTREXONE | 380MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Prescription | Yes | AP | 021897 | ALKERMES |