Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077312
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENTANYL CITRATE FENTANYL CITRATE EQ 0.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Discontinued None No No
FENTANYL CITRATE FENTANYL CITRATE EQ 0.4MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Discontinued None No No
FENTANYL CITRATE FENTANYL CITRATE EQ 0.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Discontinued None No No
FENTANYL CITRATE FENTANYL CITRATE EQ 0.8MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Discontinued None No No
FENTANYL CITRATE FENTANYL CITRATE EQ 1.2MG BASE TROCHE/LOZENGE;TRANSMUCOSAL Discontinued None No No
FENTANYL CITRATE FENTANYL CITRATE EQ 1.6MG BASE TROCHE/LOZENGE;TRANSMUCOSAL 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
10/30/2009 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077312lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077312s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/07/2017 SUPPL-9 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/14/2017 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/24/2014 SUPPL-6 REMS-Modified

Label is not available on this site.

11/07/2013 SUPPL-5 REMS-Modified

Label is not available on this site.

06/29/2012 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

06/08/2012 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/28/2011 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide, REMS-Proposal

Label is not available on this site.

01/20/2012 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/30/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077312lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English