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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 022473

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NDA 022473 describes REVATIO, which is a drug marketed by Viatris and is included in three NDAs. It is available from four 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. Sixty-two suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

Summary for 022473

Tradename:	REVATIO
Applicant:	Viatris
Ingredient:	sildenafil citrate
Patents:	0

Pharmacology for NDA: 022473

Mechanism of Action	Phosphodiesterase 5 Inhibitors

Medical Subject Heading (MeSH) Categories for 022473

Phosphodiesterase 5 Inhibitors
Urological Agents
Vasodilator Agents

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
REVATIO	sildenafil citrate	SOLUTION;INTRAVENOUS	022473	NDA	Viatris Specialty LLC	58151-395	58151-395-31	1 VIAL in 1 CARTON (58151-395-31) / 12.5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
Approval Date:	Nov 18, 2009	TE:	AP	RLD:	Yes
Regulatory Exclusivity Expiration:	Jan 31, 2026
Regulatory Exclusivity Use:	LABELING REGARDING NEW DOSING REGIMEN IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) AND TREATMENT OF PAH IN PEDIATRIC PATIENTS (AGES 1-17)

Expired US Patents for NDA 022473

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	REVATIO	sildenafil citrate	SOLUTION;INTRAVENOUS	022473-001	Nov 18, 2009	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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