Details for New Drug Application (NDA): 020747
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The generic ingredient in ACTIQ is fentanyl citrate. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
Summary for 020747
| Tradename: | ACTIQ |
| Applicant: | Cephalon |
| Ingredient: | fentanyl citrate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TROCHE/LOZENGE;TRANSMUCOSAL | Strength | EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 4, 1998 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TROCHE/LOZENGE;TRANSMUCOSAL | Strength | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 4, 1998 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TROCHE/LOZENGE;TRANSMUCOSAL | Strength | EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 4, 1998 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020747
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-005 | Nov 4, 1998 | ⤷ Start Trial | ⤷ Start Trial |
| Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-001 | Nov 4, 1998 | ⤷ Start Trial | ⤷ Start Trial |
| Cephalon | ACTIQ | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747-003 | Nov 4, 1998 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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