Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022569
Company: BTCP PHARMA
Company: BTCP PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAZANDA | FENTANYL CITRATE | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED;NASAL | Discontinued | None | Yes | No |
| LAZANDA | FENTANYL CITRATE | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED;NASAL | Discontinued | None | Yes | No |
| LAZANDA | FENTANYL CITRATE | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED;NASAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 06/30/2011 | 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/2011/022569s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022569s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022569Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022569Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/08/2022 | SUPPL-33 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022569Orig1s033ltr.pdf |
| 08/17/2022 | SUPPL-32 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022569Orig1s032ltr.pdf |
| 12/03/2021 | SUPPL-31 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022569Orig1s031Correctedltr.pdf |
| 03/04/2021 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022569s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022569Orig1s030ltr.pdf | |
| 12/23/2020 | SUPPL-29 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022569Orig1s029ltr.pdf |
| 10/07/2019 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022569s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022569Orig1s027ltr.pdf | |
| 09/07/2017 | SUPPL-26 | REMS-Proposal |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022569Orig1s026ltr.pdf |
| 03/21/2017 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022569s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022569Orig1s024ltr.pdf | |
| 12/16/2016 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022569s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022569Orig1s023ltr.pdf | |
| 12/21/2015 | SUPPL-22 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022569Orig1s022ltr.pdf |
| 09/30/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/24/2014 | SUPPL-20 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022569s013s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022569Orig1s013,022569Orig1s019,022569Orig1s020ltr.pdf | |
| 12/24/2014 | SUPPL-19 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022569s013s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022569Orig1s013,022569Orig1s019,022569Orig1s020ltr.pdf | |
| 04/07/2014 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/2013 | SUPPL-17 | REMS-Assessment |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022569Orig1s012,s015,s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022569Orig1s012,s015,s017ltr.pdf | |
| 08/11/2015 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/2013 | SUPPL-15 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022569Orig1s012,s015,s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022569Orig1s012,s015,s017ltr.pdf | |
| 12/24/2014 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022569s013s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022569Orig1s013,022569Orig1s019,022569Orig1s020ltr.pdf | |
| 11/07/2013 | SUPPL-12 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022569Orig1s012,s015,s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022569Orig1s012,s015,s017ltr.pdf | |
| 06/05/2012 | SUPPL-7 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022569s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022569s007ltr.pdf | |
| 12/28/2011 | SUPPL-5 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022569s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022569s005ltr.pdf | |
| 11/04/2011 | SUPPL-2 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022569s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022569s030lbl.pdf | |
| 10/07/2019 | SUPPL-27 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022569s027lbl.pdf | |
| 10/07/2019 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022569s027lbl.pdf | |
| 03/21/2017 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022569s024lbl.pdf | |
| 12/16/2016 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022569s023lbl.pdf | |
| 12/16/2016 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022569s023lbl.pdf | |
| 12/24/2014 | SUPPL-20 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022569s013s019s020lbl.pdf | |
| 12/24/2014 | SUPPL-19 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022569s013s019s020lbl.pdf | |
| 12/24/2014 | SUPPL-13 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022569s013s019s020lbl.pdf | |
| 12/24/2014 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022569s013s019s020lbl.pdf | |
| 11/07/2013 | SUPPL-17 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022569Orig1s012,s015,s017lbl.pdf | |
| 11/07/2013 | SUPPL-15 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022569Orig1s012,s015,s017lbl.pdf | |
| 11/07/2013 | SUPPL-12 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022569Orig1s012,s015,s017lbl.pdf |
| 06/05/2012 | SUPPL-7 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022569s007lbl.pdf | |
| 12/28/2011 | SUPPL-5 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022569s005lbl.pdf | |
| 06/30/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022569s000lbl.pdf |