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Generated: December 16, 2018

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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. It is available from one supplier. 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. Sixteen 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
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 017849
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRETHINE terbutaline sulfate TABLET;ORAL 017849 NDA AUTHORIZED GENERIC ANI Pharmaceuticals, Inc. 62559-721 62559-721-01 100 TABLET in 1 BOTTLE (62559-721-01)
BRETHINE terbutaline sulfate TABLET;ORAL 017849 NDA AUTHORIZED GENERIC ANI Pharmaceuticals, Inc. 62559-722 62559-722-01 100 TABLET in 1 BOTTLE (62559-722-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage: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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage: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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:ABRLD: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 017849-001 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 017849-002 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:

Chubb
Chinese Patent Office
Moodys
Boehringer Ingelheim
Fish and Richardson
US Army
McKinsey
Mallinckrodt
US Department of Justice

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