Details for New Drug Application (NDA): 021845
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The generic ingredient in REVATIO is sildenafil citrate. There are twenty drug master file entries for this compound. Sixty-eight 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
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Viatris | REVATIO | sildenafil citrate | TABLET;ORAL | 021845-001 | Jun 3, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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