Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075343
Company: TEVA PHARMS
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
11/09/1999 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75343ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75343_Albuterol.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/27/2001 SUPPL-2 Labeling

Label is not available on this site.

08/27/2001 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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