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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021543
Company: AUXILIUM PHARMS LLC

Products on NDA 021543

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STRIANT	TESTOSTERONE	30MG	TABLET, EXTENDED RELEASE;BUCCAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021543

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/2003	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21543_striant_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21543ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-543_Striant.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2016	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021543s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021543Orig1s012ltr.pdf
05/11/2015	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021543s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021543Orig1s011ltr.pdf
06/19/2014	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021543s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021543Orig1s010ltr.pdf
03/21/2014	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021543s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021543Orig1s009ltr.pdf
11/05/2004	SUPPL-2	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21543s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21543s002ltr.pdf
11/03/2003	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21543slr001ltr.pdf

Labels for NDA 021543

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2016	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021543s012lbl.pdf
05/11/2015	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021543s011lbl.pdf
06/19/2014	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021543s010lbl.pdf
03/21/2014	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021543s009lbl.pdf
03/21/2014	SUPPL-9	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021543s009lbl.pdf
11/05/2004	SUPPL-2	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21543s002lbl.pdf
06/19/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21543_striant_lbl.pdf

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