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Serving 500+ biopharmaceutical companies globally:

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Generated: August 24, 2017

DrugPatentWatch Database Preview

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. Seventeen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

Summary for NDA: 016619

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Analgesics
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, Inc. 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, Inc. 17478-030 17478-030-05 10 AMPULE in 1 CARTON (17478-030-05) > 5 mL in 1 AMPULE

Summary 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 500+ biopharmaceutical companies globally:

US Army
Chubb
Boehringer Ingelheim
Moodys
Fish and Richardson
Argus Health
Dow
Mallinckrodt
Covington
QuintilesIMS

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