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Last Updated: April 25, 2024

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.
Summary for 019101
Ingredient:fentanyl citrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 019101
Mechanism of ActionFull 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:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/ML
Approval Date:Jul 11, 1984TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.025MG BASE/0.5ML
Approval Date:Jan 20, 2023TE:RLD:Yes

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