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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077312
Company: PAR PHARM

Medication Guide

REMS

Products on ANDA 077312

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077312

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.

Labels for ANDA 077312

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

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