Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020837
Company: OAK PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription AN Yes Yes
XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription AN Yes Yes
XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription AN Yes Yes
XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION;INHALATION Prescription AN 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
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

XOPENEX

SOLUTION;INHALATION; EQ 0.021% BASE
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription No AN 207625 AUROBINDO PHARMA LTD
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription No AN 078171 CIPLA
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription No AN 077756 IMPAX LABS INC
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription No AN 077800 MYLAN SPECIALITY LP
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription No AN 203653 RITEDOSE CORP
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription No AN 207820 SUN PHARM
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription No AN 090297 TEVA PHARMS USA
XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE SOLUTION;INHALATION Prescription Yes AN 020837 OAK PHARMS INC

SOLUTION;INHALATION; EQ 0.042% BASE
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription No AN 207625 AUROBINDO PHARMA LTD
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription No AN 078171 CIPLA
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription No AN 077756 IMPAX LABS INC
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription No AN 077800 MYLAN SPECIALITY LP
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription No AN 203653 RITEDOSE CORP
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription No AN 207820 SUN PHARM
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription No AN 090297 TEVA PHARMS USA
XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE SOLUTION;INHALATION Prescription Yes AN 020837 OAK PHARMS INC

SOLUTION;INHALATION; EQ 0.0103% BASE
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription No AN 207625 AUROBINDO PHARMA LTD
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription No AN 078171 CIPLA
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription No AN 077756 IMPAX LABS INC
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription No AN 077800 MYLAN SPECIALITY LP
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription No AN 203653 RITEDOSE CORP
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription No AN 207820 SUN PHARM
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription No AN 090297 TEVA PHARMS USA
XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE SOLUTION;INHALATION Prescription Yes AN 020837 OAK PHARMS INC

SOLUTION;INHALATION; EQ 0.25% BASE
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION;INHALATION Prescription No AN 207628 AUROBINDO PHARMA LTD
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION;INHALATION Prescription No AN 078309 MYLAN SPECIALITY LP
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION;INHALATION Prescription No AN 200875 TEVA PARENTERAL
XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION;INHALATION Prescription Yes AN 020837 OAK PHARMS INC

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