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| SULAR | NISOLDIPINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| SULAR | NISOLDIPINE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| SULAR | NISOLDIPINE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| SULAR | NISOLDIPINE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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| SULAR | NISOLDIPINE | 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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