Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077839
Company: RITEDOSE CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.083% 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
12/16/2008 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
01/28/2013 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

ALBUTEROL SULFATE

SOLUTION;INHALATION; EQ 0.083% BASE
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION;INHALATION Prescription No AN 206224 AUROBINDO PHARMA LTD
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION;INHALATION Prescription No AN 074880 NEPHRON
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION;INHALATION Prescription No AN 077839 RITEDOSE CORP
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION;INHALATION Prescription No AN 207857 SUN PHARMA GLOBAL

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