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Generated: January 17, 2019

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Details for New Drug Application (NDA): 022473

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NDA 022473 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 022473
Tradename:REVATIO
Applicant:Pfizer
Ingredient:sildenafil citrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 022473
Medical Subject Heading (MeSH) Categories for 022473
Suppliers and Packaging for NDA: 022473
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REVATIO sildenafil citrate SOLUTION;INTRAVENOUS 022473 NDA Pfizer Laboratories Div Pfizer Inc 0069-0338 0069-0338-01 1 VIAL in 1 CARTON (0069-0338-01) > 12.5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
Approval Date:Nov 18, 2009TE:APRLD:Yes

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