Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022276
Company: EXELA PHARMA SCIENCE
Company: EXELA PHARMA SCIENCE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG/200ML (0.1MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | None | Yes | Yes |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | NICARDIPINE HYDROCHLORIDE | 40MG/200ML (0.2MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 07/24/2008 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022276lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022276s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022276s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022276s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/23/2016 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022276Orig1s011ltr.pdf | |
| 10/28/2014 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2016 | SUPPL-8 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022276Orig1s008ltr_.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/022276Orig1s008.pdf | |
| 01/10/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/2009 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022276s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022276s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/23/2016 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s011lbl.pdf | |
| 04/07/2016 | SUPPL-8 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s008lbl.pdf |
| 01/08/2009 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022276s003lbl.pdf | |
| 07/24/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022276lbl.pdf |
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