Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203760
Company: PERRIGO PHARMS CO
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 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
02/24/2020 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203760Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/203760Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/29/2020 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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