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Last Updated: September 27, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020144


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NDA 020144 describes TRANSDERM-NITRO, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the TRANSDERM-NITRO profile page.

The generic ingredient in TRANSDERM-NITRO is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 020144
Tradename:TRANSDERM-NITRO
Applicant:Novartis
Ingredient:nitroglycerin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020144
Paragraph IV (Patent) Challenges for 020144
Tradename Dosage Ingredient NDA Submissiondate
TRANSDERM-NITRO FILM, EXTENDED RELEASE;TRANSDERMAL nitroglycerin 020144

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.1MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 27, 1996TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.2MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 27, 1996TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.4MG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 27, 1996TE:RLD:Yes

Expired US Patents for NDA 020144

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-005 Feb 27, 1996 ⤷  Try it Free ⤷  Try it Free
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-001 Feb 27, 1996 ⤷  Try it Free ⤷  Try it Free
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-003 Feb 27, 1996 ⤷  Try it Free ⤷  Try it Free
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-003 Feb 27, 1996 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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