Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019734
Company: CHIESI
Company: CHIESI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARDENE | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | AP | Yes | Yes |
| CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | AP | Yes | Yes |
| CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | None | Yes | Yes |
| CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/30/1992 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/16/2022 | SUPPL-31 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019734Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019734Orig1s031ltr.pdf | |
| 07/27/2018 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019734s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019734Orig1s030Ltr.pdf | |
| 08/26/2016 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019734s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019734Orig1s027ltr.pdf | |
| 12/21/2015 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/2015 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/2014 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019734s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019734Orig1s023ltr.pdf | |
| 04/30/2014 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/2011 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019734s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019734s017ltr.pdf | |
| 01/13/2010 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019734s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019734s015ltr.pdf | |
| 11/07/2008 | SUPPL-14 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019734s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/019734Orig1s014.pdf |
| 07/31/2008 | SUPPL-13 | 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/2008/019734s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/019734Orig1s013.pdf |
| 06/22/2007 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019734s009ltr.pdf |
| 10/24/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1995 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/12/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1992 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/16/2022 | SUPPL-31 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019734Orig1s031lbl.pdf | |
| 09/16/2022 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019734Orig1s031lbl.pdf | |
| 07/27/2018 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019734s030lbl.pdf | |
| 08/26/2016 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019734s027lbl.pdf | |
| 07/23/2014 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019734s023lbl.pdf | |
| 02/07/2011 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019734s017lbl.pdf | |
| 01/13/2010 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019734s015lbl.pdf |
CARDENE
There are no Therapeutic Equivalents.
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
INJECTABLE;INTRAVENOUS; 40MG/200ML (0.2MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 019734 | CHIESI |
| NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203978 | INFORLIFE |
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
INJECTABLE;INTRAVENOUS; 20MG/200ML (0.1MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 019734 | CHIESI |
| NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203978 | INFORLIFE |
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.