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Generated: January 16, 2019

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Details for New Drug Application (NDA): 021845

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NDA 021845 describes REVATIO, which is a drug marketed by Pfizer and is included in three NDAs. It is available from five suppliers. Additional details are available on the REVATIO profile page.

The generic ingredient in REVATIO 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 021845
Tradename:REVATIO
Applicant:Pfizer
Ingredient:sildenafil citrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021845
Medical Subject Heading (MeSH) Categories for 021845
Suppliers and Packaging for NDA: 021845
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REVATIO sildenafil citrate TABLET;ORAL 021845 NDA Pfizer Laboratories Div Pfizer Inc 0069-4190 0069-4190-68 90 TABLET, FILM COATED in 1 BOTTLE (0069-4190-68)
REVATIO sildenafil citrate TABLET;ORAL 021845 NDA AUTHORIZED GENERIC KAISER FOUNDATION HOSPITALS 0179-0160 0179-0160-08 8 TABLET, FILM COATED in 1 BOTTLE (0179-0160-08)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jun 3, 2005TE:ABRLD:Yes

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