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Details for New Drug Application (NDA): 021134

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NDA 021134 describes NITROSTAT, which is a drug marketed by Pfizer Pharms and Parke Davis 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-six suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the nitroglycerin profile page.

Summary for NDA: 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

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.3MG
Approval Date:May 1, 2000TE:ABRLD:No
Patent:6,500,456Patent Expiration:Sep 16, 2018Product Flag?Substance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.4MG
Approval Date:May 1, 2000TE:ABRLD:No
Patent:6,500,456Patent Expiration:Sep 16, 2018Product Flag?Substance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength0.6MG
Approval Date:May 1, 2000TE:ABRLD:Yes
Patent:6,500,456Patent Expiration:Sep 16, 2018Product Flag?Substance Flag?Delist Request?


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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.

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