Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
XOPENEX | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION;INHALATION | Discontinued | None | Yes | No |
XOPENEX | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION;INHALATION | Discontinued | None | Yes | No |
XOPENEX | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION;INHALATION | Discontinued | None | Yes | No |
XOPENEX | LEVALBUTEROL HYDROCHLORIDE | EQ 0.25% BASE | SOLUTION;INHALATION | 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 |
---|---|---|---|---|---|---|---|
03/25/1999 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20837lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20837ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20837_Xenopex.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/03/2019 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020837s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020837Orig1s044ltr.pdf | |
03/31/2015 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020837s043lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020837Orig1s043ltr.pdf | |
12/15/2014 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/22/2015 | SUPPL-41 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020837s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020837Orig1s041ltr.pdf | |
01/15/2014 | SUPPL-40 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020837Orig1s040ltr.pdf |
03/31/2014 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020837s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020837Orig1s039ltr.pdf | |
09/20/2013 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020837s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020837Orig1s038ltr.pdf | |
01/09/2013 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/07/2012 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020837s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020837Orig1s036ltr.pdf | |
01/09/2013 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/07/2006 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020837s020_ltr.pdf |
07/18/2003 | SUPPL-10 | Manufacturing (CMC)-Control |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20837scs010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020837_S010_Xopenex_APPROVAL PACKAGE.pdf |
08/07/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/04/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/30/2002 | SUPPL-6 | Efficacy-New Patient Population |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20837S6lbl.pdf | |
02/16/2001 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
12/04/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/12/2000 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
09/21/1999 | 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 |
---|---|---|---|---|---|
01/03/2019 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020837s044lbl.pdf | |
03/31/2015 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020837s043lbledt.pdf | |
01/22/2015 | SUPPL-41 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020837s041lbl.pdf | |
03/31/2014 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020837s039lbl.pdf | |
09/20/2013 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020837s038lbl.pdf | |
09/07/2012 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020837s036lbl.pdf | |
01/30/2002 | SUPPL-6 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20837S6lbl.pdf | |
03/25/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20837lbl.pdf |