Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080911
Company: AUXILIUM PHARMS INC

Products on ANDA 080911

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TESTOPEL	TESTOSTERONE	75MG	PELLET;IMPLANTATION	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080911

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.