Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076737
Company: ACTAVIS LABS UT INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE TESTOSTERONE 25MG/2.5GM PACKET GEL;TRANSDERMAL Prescription AB1 No No
TESTOSTERONE TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription AB1 No No
TESTOSTERONE TESTOSTERONE 12.5MG/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
01/27/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076737ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/03/2019 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
06/03/2019 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
10/28/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
11/05/2015 SUPPL-6 REMS-Modified

Label is not available on this site.

TESTOSTERONE

GEL;TRANSDERMAL; 25MG/2.5GM PACKET
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANDROGEL TESTOSTERONE 25MG/2.5GM PACKET GEL;TRANSDERMAL Prescription Yes AB1 021015 ABBVIE
TESTOSTERONE TESTOSTERONE 25MG/2.5GM PACKET GEL;TRANSDERMAL Prescription No AB1 076737 ACTAVIS LABS UT INC

GEL;TRANSDERMAL; 50MG/5GM PACKET
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANDROGEL TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription Yes AB1 021015 ABBVIE
TESTOSTERONE TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription No AB1 076737 ACTAVIS LABS UT INC
TESTOSTERONE TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription No AB1 076744 PAR PHARM

GEL, METERED;TRANSDERMAL; 12.5MG/1.25GM ACTUATION
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANDROGEL TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED;TRANSDERMAL Prescription Yes AB 021015 ABBVIE
TESTOSTERONE TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED;TRANSDERMAL Prescription No AB 076737 ACTAVIS LABS UT INC

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