Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075063
Company: HI TECH PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.083% BASE SOLUTION;INHALATION Discontinued None 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
02/09/1999 ORIG-1 Approval Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75063ltr.pdf

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