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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

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
Formulation / Manufacturing:see details
Pharmacology for NDA: 018705
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 018705
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 Allegis Pharmaceuticals, LLC 28595-120 28595-120-12 1 BOTTLE in 1 CARTON (28595-120-12) > 200 SPRAY in 1 BOTTLE
NITROLINGUAL nitroglycerin AEROSOL;SUBLINGUAL 018705 NDA Allegis Pharmaceuticals, LLC 28595-120 28595-120-49 1 BOTTLE in 1 CARTON (28595-120-49) > 60 SPRAY in 1 BOTTLE
Paragraph IV (Patent) Challenges for 018705
Tradename Dosage Ingredient NDA Submissiondate
NITROLINGUAL AEROSOL;SUBLINGUAL nitroglycerin 018705 2012-04-17
NITROLINGUAL PUMPSPRAY SPRAY, METERED;SUBLINGUAL nitroglycerin 018705 2012-04-17

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:AEROSOL;SUBLINGUALStrength0.4MG/SPRAY
Approval Date:Oct 31, 1985TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;SUBLINGUALStrength0.4MG/SPRAY
Approval Date:Jan 10, 1997TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Mar 12, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ANGINA PECTORIS

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