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NITROL Drug Profile

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Which patents cover Nitrol, and what substitute generic drugs are available?

Nitrol is a drug marketed by Rorer and Pohl Boskamp and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

The generic ingredient in NITROL is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the nitroglycerin profile page.

Summary for Tradename: NITROL

Bulk Api Vendors: see list53
Patent Applications: see list347
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:NITROL at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
INJECTABLE;INJECTION018774-001Jan 19, 1983DISCNNoNo► Subscribe► Subscribe
Pohl Boskamp
AEROSOL;SUBLINGUAL018705-001Oct 31, 1985DISCNNoNo► Subscribe► Subscribe
Pohl Boskamp
SPRAY, METERED;SUBLINGUAL018705-002Jan 10, 1997RXYesYes7,872,049► SubscribeY ► Subscribe
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Paragraph IV activity for: NITROL

Drugname Dosage Strength RLD Submissiondate
nitroglycerinSublingual Spray400 mcg/spray, 4.9 g and 12 g bottlesNitrolingual Pumpspray4/17/2012
nitroglycerinSublingual Spray400 mcg/spray, 4.9 g and 12 g bottlesNitrolingual Pumpspray8/23/2012
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.