Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080911
Company: AUXILIUM PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOPEL TESTOSTERONE 75MG PELLET;IMPLANTATION Prescription None 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
07/13/1972 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2016 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

10/17/2016 SUPPL-22 Labeling

Label is not available on this site.

08/01/2016 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

05/11/2015 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

11/17/2014 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

04/08/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/15/1994 SUPPL-11 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/080911.pdf
02/24/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/21/1992 SUPPL-9 Labeling

Label is not available on this site.

05/08/1992 SUPPL-8 Labeling

Label is not available on this site.

09/10/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/10/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/03/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

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