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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 Pfizer Ireland and is included in one NDA. It is available from eleven 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. Thirty-five suppliers are listed for this compound. There are thirty-three tentative approvals for this compound. Additional details are available on the sildenafil citrate profile page.

Summary for NDA: 020895

Tradename:
VIAGRA
Applicant:
Pfizer Ireland
Ingredient:
sildenafil citrate
Patents:1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Mar 27, 1998TE:RLD:No
Patent:6,469,012*PEDPatent Expiration:Apr 22, 2020Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Mar 27, 1998TE:RLD:No
Patent:6,469,012*PEDPatent Expiration:Apr 22, 2020Product Flag?Substance Flag?Delist Request?Y

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Mar 27, 1998TE:RLD:Yes
Patent:6,469,012*PEDPatent Expiration:Apr 22, 2020Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020895

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Ireland
VIAGRA
sildenafil citrate
TABLET;ORAL020895-001Mar 27, 19985,250,534*PED► subscribe
Pfizer Ireland
VIAGRA
sildenafil citrate
TABLET;ORAL020895-003Mar 27, 19985,250,534*PED► subscribe
Pfizer Ireland
VIAGRA
sildenafil citrate
TABLET;ORAL020895-002Mar 27, 19985,250,534*PED► subscribe
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