Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204255
Company: PERRIGO ISRAEL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE TESTOSTERONE 30MG/1.5ML ACTUATION SOLUTION, METERED;TRANSDERMAL Prescription AT No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/28/2017 ORIG-1 Approval Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204255Orig1s000lbl.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/31/2019 SUPPL-5 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/10/2019 SUPPL-4 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/24/2019 SUPPL-3 Labeling-Container/Carton Labels

Label is not available on this site.

04/24/2019 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/28/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204255Orig1s000lbl.pdf

TESTOSTERONE

SOLUTION, METERED;TRANSDERMAL; 30MG/1.5ML ACTUATION
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TESTOSTERONE TESTOSTERONE 30MG/1.5ML ACTUATION SOLUTION, METERED;TRANSDERMAL Prescription No AT 205328 ACTAVIS LABS UT INC
TESTOSTERONE TESTOSTERONE 30MG/1.5ML ACTUATION SOLUTION, METERED;TRANSDERMAL Prescription No AT 209533 CIPLA
TESTOSTERONE TESTOSTERONE 30MG/1.5ML ACTUATION SOLUTION, METERED;TRANSDERMAL Prescription No AT 208061 LUPIN LTD
TESTOSTERONE TESTOSTERONE 30MG/1.5ML ACTUATION SOLUTION, METERED;TRANSDERMAL Prescription No AT 204255 PERRIGO ISRAEL

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