Details for New Drug Application (NDA): 212312
✉ Email this page to a colleague
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 212312
Tradename: | SILDENAFIL CITRATE |
Applicant: | Tris Pharma Inc |
Ingredient: | sildenafil citrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212312
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 212312
Suppliers and Packaging for NDA: 212312
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SILDENAFIL CITRATE | sildenafil citrate | FOR SUSPENSION;ORAL | 212312 | ANDA | Tris Pharma Inc | 27808-163 | 27808-163-01 | 1 BOTTLE in 1 CARTON (27808-163-01) / 112 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 10MG BASE/ML | ||||
Approval Date: | Nov 17, 2021 | TE: | RLD: | No |
Complete Access Available with Subscription