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Queensland Health
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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205474

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NDA 205474 describes OBREDON, which is a drug marketed by Sovereign Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the OBREDON profile page.

The generic ingredient in OBREDON is guaifenesin; hydrocodone bitartrate. There are twenty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the guaifenesin; hydrocodone bitartrate profile page.
Summary for 205474
Tradename:OBREDON
Applicant:Sovereign Pharms
Ingredient:guaifenesin; hydrocodone bitartrate
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 205474
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 205474
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OBREDON guaifenesin; hydrocodone bitartrate SOLUTION;ORAL 205474 NDA NOVOTEC PHARMA LLC 69166-523 N 69166-523-04
OBREDON guaifenesin; hydrocodone bitartrate SOLUTION;ORAL 205474 NDA NOVOTEC PHARMA LLC 69166-523 N 69166-523-16

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength200MG/5ML;2.5MG/5ML
Approval Date:Nov 14, 2014TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 13, 2035Product Flag?YSubstance Flag?YDelist Request?
Patented Use:A METHOD OF INCREASING THE BIOAVAILABILITY OF GUAIFENESIN IN A SOLUTION CONTAINING 54% TO 66% BY WEIGHT OF PROPYLENE GLYCOL AND GLYCEROL, WHEREIN THE METHOD INCREASES THE CMAX BY AT LEAST 1.5 AND/OR INCREASES THE AUC (0-INF) BY AT LEAST 1.4

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Chinese Patent Office
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Boehringer Ingelheim
Harvard Business School
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