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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 013621

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NDA 013621 describes PERTOFRANE, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the PERTOFRANE profile page.

The generic ingredient in PERTOFRANE is desipramine hydrochloride. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the desipramine hydrochloride profile page.

Summary for 013621

Tradename:	PERTOFRANE
Applicant:	Sanofi Aventis Us
Ingredient:	desipramine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 013621

Adrenergic Uptake Inhibitors
Antidepressive Agents, Tricyclic
Enzyme Inhibitors

Profile for product number 001

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

Expired US Patents for NDA 013621

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-001	Approved Prior to Jan 1, 1982	3,454,554	⤷ Get Started Free
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-002	Approved Prior to Jan 1, 1982	3,454,698	⤷ Get Started Free
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-002	Approved Prior to Jan 1, 1982	3,454,554	⤷ Get Started Free
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-001	Approved Prior to Jan 1, 1982	3,454,698	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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