Details for New Drug Application (NDA): 018705

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NDA 018705 describes NITROLINGUAL PUMPSPRAY, which is a drug marketed by Pohl Boskamp and is included in one NDA. It is available from five suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the NITROLINGUAL PUMPSPRAY profile page.

The generic ingredient in NITROLINGUAL PUMPSPRAY is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

Summary for 018705

Tradename:	NITROLINGUAL PUMPSPRAY
Applicant:	Pohl Boskamp
Ingredient:	nitroglycerin
Patents:	1

Pharmacology for NDA: 018705

Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for 018705

Explosive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 018705

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NITROLINGUAL	nitroglycerin	AEROSOL;SUBLINGUAL	018705	NDA	INDEPENDENCE PHARMACEUTICALS, LLC	21724-100	21724-100-41	1 BOTTLE, SPRAY in 1 CARTON (21724-100-41) / 200 SPRAY in 1 BOTTLE, SPRAY
NITROLINGUAL	nitroglycerin	AEROSOL;SUBLINGUAL	018705	NDA	INDEPENDENCE PHARMACEUTICALS, LLC	21724-100	21724-100-50	1 BOTTLE, SPRAY in 1 CARTON (21724-100-50) / 60 SPRAY in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	AEROSOL;SUBLINGUAL			Strength	0.4MG/SPRAY
Approval Date:	Oct 31, 1985	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;SUBLINGUAL			Strength	0.4MG/SPRAY
Approval Date:	Jan 10, 1997	TE:	AB	RLD:	Yes
Patent:	7,872,049	Patent Expiration:	Mar 12, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING ANGINA PECTORIS

Expired US Patents for NDA 018705

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pohl Boskamp	NITROLINGUAL PUMPSPRAY	nitroglycerin	SPRAY, METERED;SUBLINGUAL	018705-002	Jan 10, 1997	5,186,925	⤷ Subscribe
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