Details for New Drug Application (NDA): 212086
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NDA 212086 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 212086
| Tradename: | FENTANYL CITRATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | fentanyl citrate |
| Patents: | 0 |
Pharmacology for NDA: 212086
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 212086
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FENTANYL CITRATE | fentanyl citrate | INJECTABLE;INJECTION | 212086 | ANDA | Fresenius Kabi USA, LLC | 63323-808 | 63323-808-11 | 10 SYRINGE in 1 CARTON (63323-808-11) / 1 mL in 1 SYRINGE (63323-808-01) |
| FENTANYL CITRATE | fentanyl citrate | INJECTABLE;INJECTION | 212086 | ANDA | Fresenius Kabi USA, LLC | 63323-810 | 63323-810-20 | 20 SYRINGE in 1 CARTON (63323-810-20) / 2 mL in 1 SYRINGE (63323-810-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.05MG BASE/ML | ||||
| Approval Date: | Sep 1, 2020 | TE: | AP | RLD: | No | ||||
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