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Generated: December 16, 2017

DrugPatentWatch Database Preview

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. Forty-two suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

Summary for 020145

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020145

Ingredient-typeNitrates
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 Merck Sharp & Dohme Corp. 0085-0819 0085-0819-30 30 POUCH in 1 BOX, UNIT-DOSE (0085-0819-30) > 1 PATCH in 1 POUCH
NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145 NDA Merck Sharp & Dohme Corp. 0085-0819 0085-0819-35 30 POUCH in 1 PACKAGE (0085-0819-35) > 1 PATCH in 1 POUCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.1MG/HR
Approval Date:Apr 4, 1995TE:AB1RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.2MG/HR
Approval Date:Apr 4, 1995TE:AB1RLD:Yes

Summary for product number 003

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

Expired Orange Book Patents for NDA: 020145

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
UspharmaNITRO-DURnitroglycerinFILM, EXTENDED RELEASE;TRANSDERMAL020145-001Apr 4, 1995► Subscribe► Subscribe
UspharmaNITRO-DURnitroglycerinFILM, EXTENDED RELEASE;TRANSDERMAL020145-006Apr 4, 1995► Subscribe► Subscribe
UspharmaNITRO-DURnitroglycerinFILM, EXTENDED RELEASE;TRANSDERMAL020145-004Apr 4, 1995► Subscribe► Subscribe
UspharmaNITRO-DURnitroglycerinFILM, EXTENDED RELEASE;TRANSDERMAL020145-005Apr 4, 1995► Subscribe► Subscribe
UspharmaNITRO-DURnitroglycerinFILM, EXTENDED RELEASE;TRANSDERMAL020145-003Apr 4, 1995► Subscribe► Subscribe
UspharmaNITRO-DURnitroglycerinFILM, EXTENDED RELEASE;TRANSDERMAL020145-002Apr 4, 1995► Subscribe► Subscribe
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