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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020837
Company: HIKMA

Products on NDA 020837

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020837

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.

Labels for NDA 020837

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

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