Drugs@FDA: FDA Approved Drug Products

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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 TABLET;SUBLINGUAL Prescription AB Yes No
ABSTRAL FENTANYL CITRATE EQ 0.2MG BASE TABLET;SUBLINGUAL Prescription AB Yes No
ABSTRAL FENTANYL CITRATE EQ 0.3MG BASE TABLET;SUBLINGUAL Prescription AB Yes No
ABSTRAL FENTANYL CITRATE EQ 0.4MG BASE TABLET;SUBLINGUAL Prescription AB Yes Yes
ABSTRAL FENTANYL CITRATE EQ 0.6MG BASE TABLET;SUBLINGUAL Prescription AB Yes No
ABSTRAL FENTANYL CITRATE EQ 0.8MG BASE TABLET;SUBLINGUAL Prescription AB 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
01/07/2011 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/2011/022510s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022510s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022510_abstral_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022510Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/07/2017 SUPPL-17 REMS-Proposal Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022510Orig1s017ltr.pdf
12/16/2016 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022510s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022510Orig1s015ltr.pdf
12/24/2014 SUPPL-14 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022510Orig1s014ltr.pdf
11/04/2014 SUPPL-13 Labeling-Medication Guide, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022510s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022510Orig1s013ltr.pdf
10/02/2013 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/26/2013 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022510s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022510Orig1s010ltr.pdf
11/07/2013 SUPPL-7 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022510Orig1s007ltr.pdf
06/05/2012 SUPPL-5 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022510s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022510s005ltr.pdf
12/28/2011 SUPPL-3 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022510s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022510s013lbl.pdf
11/04/2014 SUPPL-13 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022510s013lbl.pdf
07/26/2013 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022510s010lbl.pdf
07/26/2013 SUPPL-10 Labeling-Medication Guide 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

ABSTRAL

TABLET;SUBLINGUAL; EQ 0.1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSTRAL FENTANYL CITRATE EQ 0.1MG BASE TABLET;SUBLINGUAL Prescription Yes AB 022510 SENTYNL THERAPS INC
FENTANYL CITRATE FENTANYL CITRATE EQ 0.1MG BASE TABLET;SUBLINGUAL Prescription No AB 207338 ACTAVIS LABS FL INC

TABLET;SUBLINGUAL; EQ 0.2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSTRAL FENTANYL CITRATE EQ 0.2MG BASE TABLET;SUBLINGUAL Prescription Yes AB 022510 SENTYNL THERAPS INC
FENTANYL CITRATE FENTANYL CITRATE EQ 0.2MG BASE TABLET;SUBLINGUAL Prescription No AB 207338 ACTAVIS LABS FL INC

TABLET;SUBLINGUAL; EQ 0.3MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSTRAL FENTANYL CITRATE EQ 0.3MG BASE TABLET;SUBLINGUAL Prescription Yes AB 022510 SENTYNL THERAPS INC
FENTANYL CITRATE FENTANYL CITRATE EQ 0.3MG BASE TABLET;SUBLINGUAL Prescription No AB 207338 ACTAVIS LABS FL INC

TABLET;SUBLINGUAL; EQ 0.4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSTRAL FENTANYL CITRATE EQ 0.4MG BASE TABLET;SUBLINGUAL Prescription Yes AB 022510 SENTYNL THERAPS INC
FENTANYL CITRATE FENTANYL CITRATE EQ 0.4MG BASE TABLET;SUBLINGUAL Prescription No AB 207338 ACTAVIS LABS FL INC

TABLET;SUBLINGUAL; EQ 0.6MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSTRAL FENTANYL CITRATE EQ 0.6MG BASE TABLET;SUBLINGUAL Prescription Yes AB 022510 SENTYNL THERAPS INC
FENTANYL CITRATE FENTANYL CITRATE EQ 0.6MG BASE TABLET;SUBLINGUAL Prescription No AB 207338 ACTAVIS LABS FL INC

TABLET;SUBLINGUAL; EQ 0.8MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABSTRAL FENTANYL CITRATE EQ 0.8MG BASE TABLET;SUBLINGUAL Prescription Yes AB 022510 SENTYNL THERAPS INC
FENTANYL CITRATE FENTANYL CITRATE EQ 0.8MG BASE TABLET;SUBLINGUAL Prescription No AB 207338 ACTAVIS LABS FL INC

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