Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200875
Company: TEVA PARENTERAL
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
09/11/2014 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/11/2016 SUPPL-3 Labeling-Container/Carton Labels

Label is not available on this site.

11/17/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/17/2015 SUPPL-1 Labeling-Patient Package Insert, 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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