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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
Citi
Cerilliant
US Army
Fish and Richardson
Baxter
Cantor Fitzgerald
McKinsey

Generated: June 19, 2018

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. Fifteen suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.
Summary for 017849
Tradename:BRETHINE
Applicant:Ani Pharms Inc
Ingredient:terbutaline sulfate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Profile 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Profile 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 US Patents for NDA 017849

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms Inc BRETHINE terbutaline sulfate TABLET;ORAL 017849-002 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Ani Pharms Inc BRETHINE terbutaline sulfate TABLET;ORAL 017849-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Ani Pharms Inc BRETHINE terbutaline sulfate TABLET;ORAL 017849-002 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Ani Pharms Inc BRETHINE terbutaline sulfate TABLET;ORAL 017849-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Daiichi Sankyo
Medtronic
Cipla
Moodys
Julphar
Accenture
Healthtrust
Cerilliant

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