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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200630
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TADALAFIL TADALAFIL 20MG TABLET;ORAL 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
08/03/2018 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200630Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/29/2021 SUPPL-5 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

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