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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022510
Company: SENTYNL THERAPS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABSTRAL FENTANYL CITRATE EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;SUBLINGUAL Discontinued None Yes No
ABSTRAL FENTANYL CITRATE EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;SUBLINGUAL Discontinued None Yes No
ABSTRAL FENTANYL CITRATE EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;SUBLINGUAL Discontinued None Yes No
ABSTRAL FENTANYL CITRATE EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;SUBLINGUAL Discontinued None Yes No
ABSTRAL FENTANYL CITRATE EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;SUBLINGUAL Discontinued None Yes No
ABSTRAL FENTANYL CITRATE EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;SUBLINGUAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/07/2019 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022510s018lbl.pdf
10/07/2019 SUPPL-18 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022510s018lbl.pdf
12/16/2016 SUPPL-15 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022510s015lbl.pdf
12/16/2016 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022510s015lbl.pdf
11/04/2014 SUPPL-13 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022510s013lbl.pdf
11/04/2014 SUPPL-13 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022510s013lbl.pdf
07/26/2013 SUPPL-10 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022510s010lbl.pdf
07/26/2013 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022510s010lbl.pdf
06/05/2012 SUPPL-5 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022510s005lbl.pdf
12/28/2011 SUPPL-3 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s003lbl.pdf
01/07/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s000lbl.pdf
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