Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205781
Company: PERRIGO UK FINCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL;TRANSDERMAL Prescription AB2 No No
TESTOSTERONE TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL;TRANSDERMAL Prescription AB2 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
07/12/2017 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205781Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205781Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/27/2019 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/12/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205781Orig1s000lbl.pdf

TESTOSTERONE

GEL;TRANSDERMAL; 1.62% (20.25MG/1.25GM PACKET)
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANDROGEL TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL;TRANSDERMAL Prescription Yes AB2 022309 ABBVIE
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL;TRANSDERMAL Prescription No AB2 205781 PERRIGO UK FINCO

GEL;TRANSDERMAL; 1.62% (40.5MG/2.5GM PACKET)
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANDROGEL TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL;TRANSDERMAL Prescription Yes AB2 022309 ABBVIE
TESTOSTERONE TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL;TRANSDERMAL Prescription No AB2 205781 PERRIGO UK FINCO

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