Details for New Drug Application (NDA): 202025
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The generic ingredient in SILDENAFIL CITRATE is sildenafil citrate. There are twenty drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for 202025
Tradename: | SILDENAFIL CITRATE |
Applicant: | Amneal Pharms |
Ingredient: | sildenafil citrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202025
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 202025
Suppliers and Packaging for NDA: 202025
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 202025 | ANDA | AvPAK | 50268-717 | 50268-717-15 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-717-15) / 1 TABLET in 1 BLISTER PACK (50268-717-11) |
SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 202025 | ANDA | Northwind Pharmaceuticals, LLC | 51655-172 | 51655-172-20 | 20 TABLET in 1 BOTTLE, PLASTIC (51655-172-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Feb 28, 2013 | TE: | AB | RLD: | No |
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