Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022569
Company: DEPOMED INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAZANDA FENTANYL CITRATE EQ 0.1MG BASE SPRAY, METERED;NASAL Prescription None Yes No
LAZANDA FENTANYL CITRATE EQ 0.4MG BASE SPRAY, METERED;NASAL Prescription None Yes Yes
LAZANDA FENTANYL CITRATE EQ 0.3MG BASE SPRAY, METERED;NASAL Prescription 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
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
03/21/2017 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

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