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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 019101


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NDA 019101 describes FENTANYL CITRATE PRESERVATIVE FREE, which is a drug marketed by Dr Reddys, Fresenius Kabi Usa, Hikma, and Hospira, and is included in four NDAs. It is available from three suppliers. Additional details are available on the FENTANYL CITRATE PRESERVATIVE FREE profile page.

The generic ingredient in FENTANYL CITRATE PRESERVATIVE FREE is fentanyl citrate. There are thirty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
Summary for 019101
Tradename:FENTANYL CITRATE PRESERVATIVE FREE
Applicant:Hikma
Ingredient:fentanyl citrate
Patents:0
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 PRESERVATIVE FREE 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 PRESERVATIVE FREE 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

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