Details for New Drug Application (NDA): 019101
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NDA 019101 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 019101
| Tradename: | FENTANYL CITRATE |
| Applicant: | Hikma |
| Ingredient: | fentanyl citrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019101
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 019101
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FENTANYL CITRATE | fentanyl citrate | INJECTABLE;INJECTION | 019101 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6024 | 0641-6024-10 | 10 AMPULE in 1 CARTON (0641-6024-10) / 2 mL in 1 AMPULE (0641-6024-01) |
| FENTANYL CITRATE | fentanyl citrate | INJECTABLE;INJECTION | 019101 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6025 | 0641-6025-10 | 10 AMPULE in 1 CARTON (0641-6025-10) / 5 mL in 1 AMPULE (0641-6025-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.05MG BASE/ML | ||||
| Approval Date: | Jul 11, 1984 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.025MG BASE/0.5ML | ||||
| Approval Date: | Jan 20, 2023 | TE: | RLD: | Yes | |||||
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