Details for New Drug Application (NDA): 078907
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NDA 078907 describes FENTANYL CITRATE, which is a drug marketed by Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Exela Pharma, Dr Reddys Labs Sa, Actavis Labs Fl Inc, Par Pharm, Specgx Llc, Astrazeneca, and Dr Reddys, and is included in nineteen NDAs. It is available from seven suppliers. Additional details are available on the FENTANYL CITRATE profile page.
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.
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 078907
| Tradename: | FENTANYL CITRATE |
| Applicant: | Specgx Llc |
| Ingredient: | fentanyl citrate |
| Patents: | 0 |
Pharmacology for NDA: 078907
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 078907
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FENTANYL CITRATE | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 078907 | ANDA | SpecGx LLC | 0406-9202 | 0406-9202-30 | 30 BLISTER PACK in 1 CARTON (0406-9202-30) / 1 LOZENGE in 1 BLISTER PACK |
| FENTANYL CITRATE | fentanyl citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 078907 | ANDA | SpecGx LLC | 0406-9204 | 0406-9204-30 | 30 BLISTER PACK in 1 CARTON (0406-9204-30) / 1 LOZENGE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TROCHE/LOZENGE;TRANSMUCOSAL | Strength | EQ 0.2MG BASE | ||||
| Approval Date: | Oct 30, 2009 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TROCHE/LOZENGE;TRANSMUCOSAL | Strength | EQ 0.4MG BASE | ||||
| Approval Date: | Oct 30, 2009 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TROCHE/LOZENGE;TRANSMUCOSAL | Strength | EQ 0.6MG BASE | ||||
| Approval Date: | Oct 30, 2009 | TE: | RLD: | No | |||||
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