Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021543
Company: AUXILIUM PHARMS LLC
Company: AUXILIUM PHARMS LLC
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 |
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 |
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 |