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Serving leading biopharmaceutical companies globally:

Harvard Business School
Farmers Insurance
Federal Trade Commission
Boehringer Ingelheim

Generated: December 13, 2017

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

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 69166-523-04 118 mL in 1 BOTTLE (69166-523-04)
OBREDON guaifenesin; hydrocodone bitartrate SOLUTION;ORAL 205474 NDA NOVOTEC PHARMA LLC 69166-523 69166-523-16 473 mL in 1 BOTTLE (69166-523-16)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength200MG/5ML;2.5MG/5ML
Approval Date:Nov 14, 2014TE:RLD:Yes
Patent:► SubscribePatent Expiration:Nov 13, 2035Product Flag?YSubstance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Farmers Insurance
Chinese Patent Office
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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