Details for New Drug Application (NDA): 020895
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NDA 020895 describes VIAGRA, which is a drug marketed by Viatris and is included in one NDA. It is available from three suppliers. Additional details are available on the VIAGRA profile page.
The generic ingredient in VIAGRA is sildenafil citrate. There are twenty drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
The generic ingredient in VIAGRA is sildenafil citrate. There are twenty drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for 020895
| Tradename: | VIAGRA |
| Applicant: | Viatris |
| Ingredient: | sildenafil citrate |
| Patents: | 0 |
Pharmacology for NDA: 020895
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 020895
Suppliers and Packaging for NDA: 020895
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIAGRA | sildenafil citrate | TABLET;ORAL | 020895 | NDA | PFIZER LABORATORIES DIV PFIZER INC | 0069-4200 | 0069-4200-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-4200-30) |
| VIAGRA | sildenafil citrate | TABLET;ORAL | 020895 | NDA | PFIZER LABORATORIES DIV PFIZER INC | 0069-4210 | 0069-4210-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-4210-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Mar 27, 1998 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Mar 27, 1998 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Mar 27, 1998 | TE: | AB | RLD: | Yes | ||||
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