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Generated: January 19, 2019

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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 one supplier. 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 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 Ingenus Pharmaceuticals, LLC 50742-513 50742-513-30 30 POUCH in 1 BOX, UNIT-DOSE (50742-513-30) > 1 PATCH in 1 POUCH
NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145 NDA Ingenus Pharmaceuticals, LLC 50742-514 50742-514-30 30 POUCH in 1 BOX, UNIT-DOSE (50742-514-30) > 1 PATCH in 1 POUCH

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.2MG/HR
Approval Date:Apr 4, 1995TE:AB1RLD: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 020145-005 Apr 4, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-001 Apr 4, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-002 Apr 4, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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