Details for New Drug Application (NDA): 014399

NDA 014399 describes NORPRAMIN, which is a drug marketed by Validus Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the NORPRAMIN profile page.

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

Summary for 014399

Tradename:	NORPRAMIN
Applicant:	Validus Pharms
Ingredient:	desipramine hydrochloride
Patents:	0

Pharmacology for NDA: 014399

Medical Subject Heading (MeSH) Categories for 014399

Adrenergic Uptake Inhibitors

Antidepressive Agents, Tricyclic

Enzyme Inhibitors

Suppliers and Packaging for NDA: 014399

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399	NDA	Validus Pharmaceuticals LLC	30698-007	30698-007-01	100 TABLET, SUGAR COATED in 1 BOTTLE (30698-007-01)
NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399	NDA	Validus Pharmaceuticals LLC	30698-011	30698-011-01	100 TABLET, SUGAR COATED in 1 BOTTLE (30698-011-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	75MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 014399

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-006	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-007	Feb 11, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-001	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-003	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-004	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-004	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-005	Approved Prior to Jan 1, 1982

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