Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077312
Company: PAR PHARM
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. |
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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 |