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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. 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: 022473

Tradename:
REVATIO
Applicant:
Pfizer
Ingredient:
sildenafil citrate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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

Summary 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
Regulatory Exclusivity Expiration:Jan 31, 2017
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING THE ADDITION OF SILDENAFIL TO BOSENTAN THERAPY
Regulatory Exclusivity Expiration:Jan 31, 2017
Regulatory Exclusivity Use:NEW LOWER DOSING REGIMEN FOR REVATIO IN THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) IN ADULTS
Regulatory Exclusivity Expiration:Mar 1, 2016
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Expired Orange Book Patents for NDA: 022473

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
REVATIO
sildenafil citrate
SOLUTION;INTRAVENOUS022473-001Nov 18, 20095,250,534*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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