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Last Updated: January 23, 2020

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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. There are three patents 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. Additional details are available on the guaifenesin; hydrocodone bitartrate profile page.
Summary for 205474
Tradename:OBREDON
Applicant:Sovereign Pharms
Ingredient:guaifenesin; hydrocodone bitartrate
Patents:3

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength200MG/5ML;2.5MG/5ML
Approval Date:Nov 14, 2014TE:RLD:Yes
Patent:  Start 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
Patent:  Start 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
Patent:  Start 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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