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Generated: November 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021134

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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 twelve 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. Forty 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
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 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
Patent:➤ Try a Free TrialPatent 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:➤ Try a Free TrialPatent 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:➤ Try a Free TrialPatent Expiration:Sep 16, 2018Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 021134

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

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