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 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. Twelve suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.

Summary for 017849

Tradename:	BRETHINE
Applicant:	Ani Pharms
Ingredient:	terbutaline sulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 017849

Adrenergic beta-2 Receptor Agonists
Bronchodilator Agents
Sympathomimetics
Tocolytic Agents

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:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 017849

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