Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020356
Company: COVIS
Company: COVIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SULAR | NISOLDIPINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
SULAR | NISOLDIPINE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
SULAR | NISOLDIPINE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
SULAR | NISOLDIPINE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
SULAR | NISOLDIPINE | 34MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
SULAR | NISOLDIPINE | 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
SULAR | NISOLDIPINE | 17MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
SULAR | NISOLDIPINE | 8.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/13/2017 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020356s027lbl.pdf |