Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207085
Company: SANDOZ INC
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 AB1 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
06/01/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

ALBUTEROL SULFATE

AEROSOL, METERED;INHALATION; EQ 0.09MG BASE/INH
TE Code = AB1

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 AB1 209959 CIPLA
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED;INHALATION Prescription No AB1 207085 SANDOZ INC
PROVENTIL-HFA ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED;INHALATION Prescription Yes AB1 020503 KINDEVA

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