Details for New Drug Application (NDA): 019115
✉ Email this page to a colleague
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 019115
Tradename: | FENTANYL CITRATE |
Applicant: | Hospira |
Ingredient: | fentanyl citrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019115
Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 019115
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENTANYL CITRATE | fentanyl citrate | INJECTABLE;INJECTION | 019115 | NDA | Hospira, Inc. | 0409-9093 | 0409-9093-11 | 10 AMPULE in 1 CELLO PACK (0409-9093-11) / 2 mL in 1 AMPULE (0409-9093-09) |
FENTANYL CITRATE | fentanyl citrate | INJECTABLE;INJECTION | 019115 | NDA | Hospira, Inc. | 0409-9093 | 0409-9093-32 | 10 AMPULE in 1 CELLO PACK (0409-9093-32) / 2 mL in 1 AMPULE (0409-9093-37) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.05MG BASE/ML | ||||
Approval Date: | Jan 12, 1985 | TE: | AP | RLD: | No |
Complete Access Available with Subscription