Details for New Drug Application (NDA): 021400
✉ Email this page to a colleague
NDA 021400 describes LEVITRA, which is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the LEVITRA profile page.
The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.
The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.
Summary for 021400
| Tradename: | LEVITRA |
| Applicant: | Bayer Hlthcare |
| Ingredient: | vardenafil hydrochloride |
| Patents: | 1 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 19, 2003 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jul 23, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 19, 2003 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jul 23, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 19, 2003 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jul 23, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET | ||||||||
Expired US Patents for NDA 021400
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-004 | Aug 19, 2003 | ⤷ Subscribe | ⤷ Subscribe |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-001 | Aug 19, 2003 | ⤷ Subscribe | ⤷ Subscribe |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-002 | Aug 19, 2003 | ⤷ Subscribe | ⤷ Subscribe |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-003 | Aug 19, 2003 | ⤷ Subscribe | ⤷ Subscribe |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-002 | Aug 19, 2003 | ⤷ Subscribe | ⤷ Subscribe |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-004 | Aug 19, 2003 | ⤷ Subscribe | ⤷ Subscribe |
| Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-001 | Aug 19, 2003 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
