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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209019
Company: PADAGIS ISRAEL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INGENOL MEBUTATE INGENOL MEBUTATE 0.05% GEL;TOPICAL 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
01/09/2019 ORIG-1 Approval STANDARD Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209019Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209019Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/19/2021 SUPPL-3 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

03/05/2021 SUPPL-2 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

08/26/2020 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

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