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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204570
Company: ACTAVIS LABS UT INC

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
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
04/10/2019 ORIG-1 Approval 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/2017/204570Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204570Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204570Orig1s000ReplacementTAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204570Orig1s000TALtr_Corrected.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204570Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2019 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.
05/16/2019 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

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 BESINS HLTHCARE
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
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 208620 ENCUBE
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 208560 LUPIN
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 204268 PADAGIS ISRAEL
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 209390 TWI PHARMS
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) GEL, METERED;TRANSDERMAL Prescription No AB 210835 XIROMED

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
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL;TRANSDERMAL Prescription No AB2 204570 ACTAVIS LABS UT INC
TESTOSTERONE TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) GEL;TRANSDERMAL Prescription No AB2 205781 PADAGIS ISRAEL

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
TESTOSTERONE TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL;TRANSDERMAL Prescription No AB2 204570 ACTAVIS LABS UT INC
TESTOSTERONE TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) GEL;TRANSDERMAL Prescription No AB2 205781 PADAGIS ISRAEL
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