Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Argus Health
US Army
UBS
Cerilliant
Julphar
AstraZeneca
Chubb
Healthtrust

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021134

« Back to Dashboard

NDA 021134 describes NITROSTAT, which is a drug marketed by Parke Davis and Pfizer Pharms and is included in five NDAs. It is available from eleven suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the NITROSTAT profile page.

The generic ingredient in NITROSTAT 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 021134
Tradename:NITROSTAT
Applicant:Pfizer Pharms
Ingredient:nitroglycerin
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021134
Ingredient-typeNitrates
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 021134
Suppliers and Packaging for NDA: 021134
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134 NDA Parke-Davis Div of Pfizer Inc 0071-0417 N 0071-0417-24
NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134 NDA Parke-Davis Div of Pfizer Inc 0071-0418 N 0071-0418-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.3MG
Approval Date:May 1, 2000TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 16, 2018Product Flag?Substance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.4MG
Approval Date:May 1, 2000TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 16, 2018Product Flag?Substance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.6MG
Approval Date:May 1, 2000TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 16, 2018Product Flag?Substance Flag?Delist Request?

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Queensland Health
Teva
Medtronic
Moodys
Boehringer Ingelheim
Colorcon
Deloitte
Daiichi Sankyo

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.