Details for New Drug Application (NDA): 020356
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NDA 020356 describes SULAR, which is a drug marketed by Covis and is included in one NDA. It is available from two suppliers. Additional details are available on the SULAR profile page.
The generic ingredient in SULAR is nisoldipine. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.
The generic ingredient in SULAR is nisoldipine. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.
Summary for 020356
| Tradename: | SULAR |
| Applicant: | Covis |
| Ingredient: | nisoldipine |
| Patents: | 0 |
Pharmacology for NDA: 020356
| Mechanism of Action | Calcium Channel Antagonists |
| Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 020356
Suppliers and Packaging for NDA: 020356
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-472 | 66993-472-02 | 1 BOTTLE in 1 CARTON (66993-472-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
| SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-473 | 66993-473-02 | 1 BOTTLE in 1 CARTON (66993-473-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Feb 2, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Feb 2, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Feb 2, 1995 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020356
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-002 | Feb 2, 1995 | 4,703,038 | ⤷ Subscribe |
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-004 | Feb 2, 1995 | 4,892,741 | ⤷ Subscribe |
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-008 | Jan 2, 2008 | 5,422,123 | ⤷ Subscribe |
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-003 | Feb 2, 1995 | 4,703,038 | ⤷ Subscribe |
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-006 | Jan 2, 2008 | 5,626,874 | ⤷ Subscribe |
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-004 | Feb 2, 1995 | 4,703,038 | ⤷ Subscribe |
| Covis | SULAR | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 020356-003 | Feb 2, 1995 | 4,892,741 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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