Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208620
Company: DR REDDYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL 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
04/10/2019 ORIG-1 Approval STANDARD Letter (PDF)
Letter (PDF)
Letter (PDF)
Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208620Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208620Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208620Orig1s000ReplacementTAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208620Orig1s000TALtr_Corrrected.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208620Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/04/2019 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/04/2019 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

TESTOSTERONE

GEL, METERED;TRANSDERMAL; 1.62% (20.25MG/1.25GM ACTUATION)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANDROGEL TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription Yes AB 022309 ABBVIE
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 204570 ACTAVIS LABS UT INC
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 207373 AMNEAL PHARMS LLC
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 208620 DR REDDYS
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 208560 LUPIN ATLANTIS
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 204268 PERRIGO ISRAEL
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 209390 TWI PHARMS

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