Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209019
Company: PERRIGO UK FINCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INGENOL MEBUTATE INGENOL MEBUTATE 0.05% GEL;TOPICAL Prescription AB 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

INGENOL MEBUTATE

GEL;TOPICAL; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INGENOL MEBUTATE INGENOL MEBUTATE 0.05% GEL;TOPICAL Prescription No AB 209019 PERRIGO UK FINCO
PICATO INGENOL MEBUTATE 0.05% GEL;TOPICAL Prescription Yes AB 202833 LEO LABS

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