Details for New Drug Application (NDA): 022473
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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 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
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 |
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Viatris | REVATIO | sildenafil citrate | SOLUTION;INTRAVENOUS | 022473-001 | Nov 18, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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