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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 014399


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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
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:RXDosage:TABLET;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD: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 014399-005 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Validus Pharms NORPRAMIN desipramine hydrochloride TABLET;ORAL 014399-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Validus Pharms NORPRAMIN desipramine hydrochloride TABLET;ORAL 014399-004 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Validus Pharms NORPRAMIN desipramine hydrochloride TABLET;ORAL 014399-006 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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