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Harvard Business School

Last Updated: March 30, 2023

Details for New Drug Application (NDA): 016619

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NDA 016619 describes SUBLIMAZE PRESERVATIVE FREE, which is a drug marketed by Akorn and is included in one NDA. It is available from one supplier. Additional details are available on the SUBLIMAZE PRESERVATIVE FREE profile page.

The generic ingredient in SUBLIMAZE 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 016619
Ingredient:fentanyl citrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 016619
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 016619
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUBLIMAZE PRESERVATIVE FREE fentanyl citrate INJECTABLE;INJECTION 016619 NDA Akorn 17478-030 17478-030-02 10 AMPULE in 1 CARTON (17478-030-02) / 2 mL in 1 AMPULE
SUBLIMAZE PRESERVATIVE FREE fentanyl citrate INJECTABLE;INJECTION 016619 NDA Akorn 17478-030 17478-030-05 10 AMPULE in 1 CARTON (17478-030-05) / 5 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Boehringer Ingelheim

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