Details for New Drug Application (NDA): 207338
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The generic ingredient in FENTANYL CITRATE is droperidol; fentanyl citrate. There are five drug master file entries for this compound. Additional details are available on the droperidol; fentanyl citrate profile page.
Summary for 207338
Tradename: | FENTANYL CITRATE |
Applicant: | Actavis Labs Fl Inc |
Ingredient: | fentanyl citrate |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 0.1MG BASE | ||||
Approval Date: | Nov 17, 2017 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 0.2MG BASE | ||||
Approval Date: | Nov 17, 2017 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 0.3MG BASE | ||||
Approval Date: | Nov 17, 2017 | TE: | RLD: | No |
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