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Generated: November 18, 2018

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Details for New Drug Application (NDA): 203109

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NDA 203109 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-one suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for 203109
Ingredient:sildenafil citrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 203109
Medical Subject Heading (MeSH) Categories for 203109
Suppliers and Packaging for NDA: 203109
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REVATIO sildenafil citrate FOR SUSPENSION;ORAL 203109 NDA Pfizer Laboratories Div Pfizer Inc 0069-0336 0069-0336-21 1 BOTTLE in 1 CARTON (0069-0336-21) > 112 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 10MG BASE/ML
Approval Date:Aug 30, 2012TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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Boehringer Ingelheim

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