Details for New Drug Application (NDA): 019101
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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 019101
Tradename: | FENTANYL CITRATE |
Applicant: | Hikma |
Ingredient: | fentanyl citrate |
Patents: | 0 |
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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