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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017849

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NDA 017849 describes BRETHINE, which is a drug marketed by Pharmacare and Ani Pharms Inc and is included in two NDAs. Additional details are available on the BRETHINE profile page.

The generic ingredient in BRETHINE is terbutaline sulfate. There are seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.

Summary for 017849

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired Orange Book Patents for NDA: 017849

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms IncBRETHINEterbutaline sulfateTABLET;ORAL017849-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Ani Pharms IncBRETHINEterbutaline sulfateTABLET;ORAL017849-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Ani Pharms IncBRETHINEterbutaline sulfateTABLET;ORAL017849-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Ani Pharms IncBRETHINEterbutaline sulfateTABLET;ORAL017849-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
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Federal Trade Commission
Baxter
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Fish and Richardson
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Medtronic
Queensland Health

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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