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Last Updated: March 19, 2026

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 five 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-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

Pharmacology for NDA: 021134

Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for 021134

Explosive Agents
Vasodilator Agents

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	Henry Schein, Inc.	0404-9800	0404-9800-01	1 BOTTLE in 1 BAG (0404-9800-01) / 25 TABLET in 1 BOTTLE
NITROSTAT	nitroglycerin	TABLET;SUBLINGUAL	021134	NDA	A-S Medication Solutions	50090-7203	50090-7203-0	1 BOTTLE in 1 CARTON (50090-7203-0) / 25 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;SUBLINGUAL			Strength	0.3MG
Approval Date:	May 1, 2000	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;SUBLINGUAL			Strength	0.4MG
Approval Date:	May 1, 2000	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;SUBLINGUAL			Strength	0.6MG
Approval Date:	May 1, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021134

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	NITROSTAT	nitroglycerin	TABLET;SUBLINGUAL	021134-001	May 1, 2000	6,500,456	⤷ Get Started Free
Viatris	NITROSTAT	nitroglycerin	TABLET;SUBLINGUAL	021134-002	May 1, 2000	6,500,456	⤷ Get Started Free
Viatris	NITROSTAT	nitroglycerin	TABLET;SUBLINGUAL	021134-003	May 1, 2000	6,500,456	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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