Details for New Drug Application (NDA): 203988
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The generic ingredient in SILDENAFIL CITRATE is sildenafil citrate. There are twenty drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for 203988
Tradename: | SILDENAFIL CITRATE |
Applicant: | Eugia Pharma |
Ingredient: | sildenafil citrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203988
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 203988
Suppliers and Packaging for NDA: 203988
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SILDENAFIL CITRATE | sildenafil citrate | SOLUTION;INTRAVENOUS | 203988 | ANDA | Eugia US LLC | 55150-166 | 55150-166-13 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-166-13) / 12.5 mL in 1 VIAL, SINGLE-DOSE |
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: | Apr 1, 2015 | TE: | AP | RLD: | No |
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