Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020356
Company: COVIS PHARMA BV
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SULAR NISOLDIPINE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
SULAR NISOLDIPINE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
SULAR NISOLDIPINE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
SULAR NISOLDIPINE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No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SULAR NISOLDIPINE 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/02/1995 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/pre96/020356Orig1s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020356Orig1s000rev.pdf
Supplements
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
05/20/2016 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/02/2008 SUPPL-19 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020356s019ltr_CKD.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020356Orig1s019.pdf
10/11/2002 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/13/2002 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/14/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/2000 SUPPL-11 Labeling

Label is not available on this site.

12/13/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/16/1998 SUPPL-9 Labeling

Label is not available on this site.

01/19/2000 SUPPL-8 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20356-s007_sular.pdf
01/19/2000 SUPPL-7 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20356-s007_sular.pdf
01/24/1997 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1997 SUPPL-5 Labeling

Label is not available on this site.

10/23/1996 SUPPL-4 Labeling

Label is not available on this site.

01/05/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1995 SUPPL-2 Labeling

Label is not available on this site.

07/26/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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

SULAR

TABLET, EXTENDED RELEASE;ORAL; 34MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NISOLDIPINE NISOLDIPINE 34MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091001 MYLAN
SULAR NISOLDIPINE 34MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020356 COVIS PHARMA BV

TABLET, EXTENDED RELEASE;ORAL; 17MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NISOLDIPINE NISOLDIPINE 17MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091001 MYLAN
SULAR NISOLDIPINE 17MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020356 COVIS PHARMA BV

TABLET, EXTENDED RELEASE;ORAL; 8.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NISOLDIPINE NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091001 MYLAN
SULAR NISOLDIPINE 8.5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020356 COVIS PHARMA BV

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