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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 018343

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NDA 018343 describes CAPOTEN, which is a drug marketed by Aarxion Anda Hlding and is included in one NDA. Additional details are available on the CAPOTEN profile page.

The generic ingredient in CAPOTEN is captopril. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the captopril profile page.

Summary for 018343

Tradename:	CAPOTEN
Applicant:	Aarxion Anda Hlding
Ingredient:	captopril
Patents:	0

Medical Subject Heading (MeSH) Categories for 018343

Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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 018343

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aarxion Anda Hlding	CAPOTEN	captopril	TABLET;ORAL	018343-004	Jun 13, 1995	⤷ Get Started Free	⤷ Get Started Free
Aarxion Anda Hlding	CAPOTEN	captopril	TABLET;ORAL	018343-001	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
Aarxion Anda Hlding	CAPOTEN	captopril	TABLET;ORAL	018343-004	Jun 13, 1995	⤷ Get Started Free	⤷ Get Started Free
Aarxion Anda Hlding	CAPOTEN	captopril	TABLET;ORAL	018343-003	Approved Prior to Jan 1, 1982	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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