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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 020145


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NDA 020145 describes NITRO-DUR, which is a drug marketed by Uspharma and is included in one NDA. It is available from two suppliers. Additional details are available on the NITRO-DUR profile page.

The generic ingredient in NITRO-DUR 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 020145
Tradename:NITRO-DUR
Applicant:Uspharma
Ingredient:nitroglycerin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020145
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 020145
Suppliers and Packaging for NDA: 020145
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145 NDA AUTHORIZED GENERIC Dr. Reddy's Laboratories, Inc. 43598-893 43598-893-30 30 POUCH in 1 BOX, UNIT-DOSE (43598-893-30) > 1 PATCH in 1 POUCH
NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145 NDA AUTHORIZED GENERIC Dr. Reddy's Laboratories, Inc. 43598-894 43598-894-30 30 POUCH in 1 BOX, UNIT-DOSE (43598-894-30) > 1 PATCH in 1 POUCH
Paragraph IV (Patent) Challenges for 020145
Tradename Dosage Ingredient NDA Submissiondate
NITRO-DUR FILM, EXTENDED RELEASE;TRANSDERMAL nitroglycerin 020145

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.1MG/HR
Approval Date:Apr 4, 1995TE:BXRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.2MG/HR
Approval Date:Apr 4, 1995TE:BXRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.3MG/HR
Approval Date:Apr 4, 1995TE:RLD:Yes

Expired US Patents for NDA 020145

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-006 Apr 4, 1995   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-001 Apr 4, 1995   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-004 Apr 4, 1995   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-003 Apr 4, 1995   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-005 Apr 4, 1995   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-002 Apr 4, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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