Details for New Drug Application (NDA): 210858
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NDA 210858 describes VYBRIQUE, which is a drug marketed by Ibsa and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the VYBRIQUE profile page.
The generic ingredient in VYBRIQUE 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 VYBRIQUE 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 210858
| Tradename: | VYBRIQUE |
| Applicant: | Ibsa |
| Ingredient: | sildenafil citrate |
| Patents: | 1 |
Pharmacology for NDA: 210858
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 210858
Suppliers and Packaging for NDA: 210858
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VYBRIQUE | sildenafil citrate | FILM;ORAL | 210858 | NDA | IBSA Pharma Inc. | 71858-0205 | 71858-0205-2 | 1 FILM in 1 POUCH (71858-0205-2) |
| VYBRIQUE | sildenafil citrate | FILM;ORAL | 210858 | NDA | IBSA Pharma Inc. | 71858-0205 | 71858-0205-4 | 1 FILM in 1 POUCH (71858-0205-4) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Dec 16, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 16, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 11,123,287 | Patent Expiration: | Dec 16, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Dec 16, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 16, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
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