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Last Updated: August 14, 2020

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Details for New Drug Application (NDA): 020895

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NDA 020895 describes VIAGRA, which is a drug marketed by Upjohn and is included in one NDA. It is available from eight suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the VIAGRA profile page.

The generic ingredient in VIAGRA is sildenafil citrate. There are twenty drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for 020895
Tradename:VIAGRA
Applicant:Upjohn
Ingredient:sildenafil citrate
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 020895
Medical Subject Heading (MeSH) Categories for 020895
Suppliers and Packaging for NDA: 020895
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIAGRA sildenafil citrate TABLET;ORAL 020895 NDA Pfizer Laboratories Div Pfizer Inc 0069-4200 0069-4200-30 30 TABLET, FILM COATED in 1 BOTTLE (0069-4200-30)
VIAGRA sildenafil citrate TABLET;ORAL 020895 NDA Pfizer Laboratories Div Pfizer Inc 0069-4210 0069-4210-30 30 TABLET, FILM COATED in 1 BOTTLE (0069-4210-30)
Paragraph IV (Patent) Challenges for 020895
Tradename Dosage Ingredient NDA Submissiondate
VIAGRA TABLET;ORAL sildenafil citrate 020895 2004-11-19
VIAGRA TABLET;ORAL sildenafil citrate 020895 2004-10-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Mar 27, 1998TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Apr 22, 2020Product Flag?Substance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Mar 27, 1998TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Apr 22, 2020Product Flag?Substance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Mar 27, 1998TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Apr 22, 2020Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 020895

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn VIAGRA sildenafil citrate TABLET;ORAL 020895-003 Mar 27, 1998   Start Trial   Start Trial
Upjohn VIAGRA sildenafil citrate TABLET;ORAL 020895-001 Mar 27, 1998   Start Trial   Start Trial
Upjohn VIAGRA sildenafil citrate TABLET;ORAL 020895-002 Mar 27, 1998   Start Trial   Start Trial
Upjohn VIAGRA sildenafil citrate TABLET;ORAL 020895-001 Mar 27, 1998   Start Trial   Start Trial
Upjohn VIAGRA sildenafil citrate TABLET;ORAL 020895-002 Mar 27, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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