Details for New Drug Application (NDA): 018571

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NDA 018571 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 018571

Tradename:	BRETHINE
Applicant:	Pharmacare
Ingredient:	terbutaline sulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 018571

Adrenergic beta-2 Receptor Agonists
Bronchodilator Agents
Sympathomimetics
Tocolytic Agents

Profile for product number 001

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Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Expired US Patents for NDA 018571

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmacare	BRETHINE	terbutaline sulfate	INJECTABLE;INJECTION	018571-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Pharmacare	BRETHINE	terbutaline sulfate	INJECTABLE;INJECTION	018571-001	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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