ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for atropine sulfate; difenoxin hydrochloride and what is the scope of freedom to operate?

Atropine sulfate; difenoxin hydrochloride is the generic ingredient in two branded drugs marketed by Sebela Ireland Ltd and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE at DailyMed

Pharmacology for ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

Drug Class	Anticholinergic Antidiarrheal Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

US Patents and Regulatory Information for ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sebela Ireland Ltd	MOTOFEN HALF-STRENGTH	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sebela Ireland Ltd	MOTOFEN	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	MOTOFEN	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Sebela Ireland Ltd	MOTOFEN HALF-STRENGTH	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-001	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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