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 |
| 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 |