Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079075
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENTANYL CITRATE FENTANYL CITRATE EQ 0.1MG BASE TABLET;BUCCAL, SUBLINGUAL Discontinued None No No
FENTANYL CITRATE FENTANYL CITRATE EQ 0.2MG BASE TABLET;BUCCAL, SUBLINGUAL Discontinued None No No
FENTANYL CITRATE FENTANYL CITRATE EQ 0.4MG BASE TABLET;BUCCAL, SUBLINGUAL Discontinued None No No
FENTANYL CITRATE FENTANYL CITRATE EQ 0.6MG BASE TABLET;BUCCAL, SUBLINGUAL Discontinued None No No
FENTANYL CITRATE FENTANYL CITRATE EQ 0.8MG BASE TABLET;BUCCAL, SUBLINGUAL 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
01/07/2011 ORIG-1 Approval Letter (PDF)
Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079075s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079075s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/079075Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/07/2017 SUPPL-13 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/12/2017 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

01/08/2016 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/08/2016 SUPPL-10 REMS-Proposal

Label is not available on this site.

05/03/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

05/03/2015 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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