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Last Updated: December 3, 2022

Details for New Drug Application (NDA): 021134


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NDA 021134 describes NITROSTAT, which is a drug marketed by Parke Davis and Viatris and is included in five NDAs. It is available from seven 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. Twenty-seven 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 Effect Vasodilation
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 021134-001 May 1, 2000 See Plans and Pricing See Plans and Pricing
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-003 May 1, 2000 See Plans and Pricing See Plans and Pricing
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-002 May 1, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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