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-three 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

Pharmacology for NDA: 020145

Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for 020145

Explosive Agents
Vasodilator Agents

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	0.1MG/HR
Approval Date:	Apr 4, 1995	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	0.2MG/HR
Approval Date:	Apr 4, 1995	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	0.3MG/HR
Approval Date:	Apr 4, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 020145

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

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