Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209954
Company: LUPIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED;INHALATION Prescription AB2 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
08/24/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/14/2021 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

ALBUTEROL SULFATE

AEROSOL, METERED;INHALATION; EQ 0.09MG BASE/INH
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED;INHALATION Prescription No AB2 209954 LUPIN
PROAIR HFA ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED;INHALATION Prescription Yes AB2 021457 TEVA BRANDED PHARM

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