Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078309
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVALBUTEROL HYDROCHLORIDE LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE SOLUTION;INHALATION Prescription AN No 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
03/20/2009 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/25/2017 SUPPL-12 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

09/25/2017 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

05/10/2013 SUPPL-9 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

02/19/2013 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

LEVALBUTEROL HYDROCHLORIDE

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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