Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022266
Company: ADALVO
Company: ADALVO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ONSOLIS | FENTANYL CITRATE | EQ 0.2MG BASE | FILM;BUCCAL | Discontinued | None | No | No |
ONSOLIS | FENTANYL CITRATE | EQ 0.4MG BASE | FILM;BUCCAL | Discontinued | None | No | No |
ONSOLIS | FENTANYL CITRATE | EQ 0.6MG BASE | FILM;BUCCAL | Discontinued | None | No | No |
ONSOLIS | FENTANYL CITRATE | EQ 0.8MG BASE | FILM;BUCCAL | Discontinued | None | No | No |
ONSOLIS | FENTANYL CITRATE | EQ 1.2MG BASE | FILM;BUCCAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/16/2009 | 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/2009/022266s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022266s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022266_onsolis_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022266s000_SumR_P1.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/17/2022 | SUPPL-27 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022266Orig1s027ltr.pdf |
12/03/2021 | SUPPL-26 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022266Orig1s026Correctedltr.pdf |
03/04/2021 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022266s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022266Orig1s025ltr.pdf | |
12/23/2020 | SUPPL-24 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022266Orig1s024ltr.pdf |
10/07/2019 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022266s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022266Orig1s023ltr.pdf | |
09/07/2017 | SUPPL-19 | REMS-Proposal |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022266Orig1s019ltr.pdf |
12/16/2016 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022266Orig1s017,s018ltr.pdf | |
12/16/2016 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022266Orig1s017,s018ltr.pdf | |
08/11/2015 | SUPPL-15 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022266s015lbl.pdf | |
12/24/2014 | SUPPL-14 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022266s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022266Orig1s014ltr.pdf | |
11/07/2013 | SUPPL-12 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022266Orig1s012ltr.pdf |
06/05/2012 | SUPPL-9 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022266s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022266s009ltr.pdf | |
12/28/2011 | SUPPL-8 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022266s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022266s008ltr.pdf | |
07/01/2010 | SUPPL-1 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022266s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022266s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/04/2021 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022266s025lbl.pdf | |
10/07/2019 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022266s023lbl.pdf | |
10/07/2019 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022266s023lbl.pdf | |
12/16/2016 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf | |
12/16/2016 | SUPPL-17 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf | |
12/16/2016 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf | |
08/11/2015 | SUPPL-15 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022266s015lbl.pdf |
12/24/2014 | SUPPL-14 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022266s014lbl.pdf | |
06/05/2012 | SUPPL-9 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022266s009lbl.pdf | |
12/28/2011 | SUPPL-8 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022266s008lbl.pdf | |
07/01/2010 | SUPPL-1 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022266s001lbl.pdf | |
07/16/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022266s000lbl.pdf |