You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 25, 2024

Details for New Drug Application (NDA): 021134


✉ Email this page to a colleague

« Back to Dashboard


NDA 021134 describes NITROSTAT, which is a drug marketed by Parke Davis and Viatris and is included in five NDAs. It is available from six suppliers. 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-three suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 021134
Tradename:NITROSTAT
Applicant:Viatris
Ingredient:nitroglycerin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021134
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 0071-0417-24 1 BOTTLE in 1 CARTON (0071-0417-24) / 100 TABLET in 1 BOTTLE
NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134 NDA Parke-Davis Div of Pfizer Inc 0071-0418 0071-0418-13 4 BOTTLE in 1 CARTON (0071-0418-13) / 25 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.3MG
Approval Date:May 1, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.4MG
Approval Date:May 1, 2000TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.6MG
Approval Date:May 1, 2000TE:ABRLD:Yes

Expired US Patents for NDA 021134

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-003 May 1, 2000 ⤷  Try a Trial ⤷  Try a Trial
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-001 May 1, 2000 ⤷  Try a Trial ⤷  Try a Trial
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-002 May 1, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.