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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 018021

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NDA 018021 describes ASENDIN, which is a drug marketed by Lederle and is included in one NDA. Additional details are available on the ASENDIN profile page.

The generic ingredient in ASENDIN is amoxapine. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amoxapine profile page.

Summary for 018021

Tradename:	ASENDIN
Applicant:	Lederle
Ingredient:	amoxapine
Patents:	0

Medical Subject Heading (MeSH) Categories for 018021

Adrenergic Uptake Inhibitors
Antidepressive Agents, Second-Generation
Dopamine Antagonists
Neurotransmitter Uptake Inhibitors
Serotonin Uptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Expired US Patents for NDA 018021

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-004	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-003	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-004	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-003	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-002	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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