Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076744
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE TESTOSTERONE 25MG/2.5GM PACKET GEL;TRANSDERMAL Discontinued None No No
TESTOSTERONE TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription AB1 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
05/23/2007 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/076744Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/03/2019 SUPPL-10 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.

06/03/2019 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/30/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

09/25/2015 SUPPL-5 REMS-Proposal

Label is not available on this site.

06/30/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

06/30/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

01/06/2009 SUPPL-1 Labeling

Label is not available on this site.

TESTOSTERONE

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

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