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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020356
Company: AZURITY

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SULAR NISOLDIPINE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
SULAR NISOLDIPINE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
SULAR NISOLDIPINE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
SULAR NISOLDIPINE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No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 Discontinued None Yes No
SULAR NISOLDIPINE 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No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 Discontinued None Yes No
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
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