Details for New Drug Application (NDA): 021845

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NDA 021845 describes REVATIO, which is a drug marketed by Viatris and is included in three NDAs. It is available from three 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-nine suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

Summary for 021845

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

Pharmacology for NDA: 021845

Mechanism of Action	Phosphodiesterase 5 Inhibitors

Medical Subject Heading (MeSH) Categories for 021845

Phosphodiesterase 5 Inhibitors
Urological Agents
Vasodilator Agents

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	Aphena Pharma Solutions - Tennessee, LLC	43353-345	43353-345-10	10 TABLET, FILM COATED in 1 BOTTLE (43353-345-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jun 3, 2005	TE:	AB	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)
Regulatory Exclusivity Expiration:	Jan 31, 2030
Regulatory Exclusivity Use:	TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP I) IN PEDIATRIC PATIENTS 1 TO 17 YEARS OLD TO IMPROVE EXERCISE ABILITY AND, IN PEDIATRIC PATIENTS TOO YOUNG TO PERFORM STANDARDIZED EXERCISE TESTING, PULMONARY HEMODYNAMICS THOUGHT TO UNDERLY IMPROVEMENTS IN EXERCISE

Expired US Patents for NDA 021845

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	REVATIO	sildenafil citrate	TABLET;ORAL	021845-001	Jun 3, 2005	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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