Details for New Drug Application (NDA): 210394
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The generic ingredient in SILDENAFIL CITRATE is sildenafil citrate. There are twenty drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for 210394
Tradename: | SILDENAFIL CITRATE |
Applicant: | Ajanta Pharma Ltd |
Ingredient: | sildenafil citrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210394
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 210394
Suppliers and Packaging for NDA: 210394
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 210394 | ANDA | Ajanta Pharma USA Inc. | 27241-124 | 27241-124-03 | 90 TABLET in 1 BOTTLE (27241-124-03) |
SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 210394 | ANDA | RPK Pharmaceuticals, Inc. | 53002-4719 | 53002-4719-3 | 30 TABLET in 1 BOTTLE (53002-4719-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | May 4, 2018 | TE: | AB | RLD: | No |
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