Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203098
Company: PERRIGO ISRAEL
Company: PERRIGO ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TESTOSTERONE | TESTOSTERONE | 12.5MG/1.25GM ACTUATION | GEL, METERED;TRANSDERMAL | Discontinued | None | No | No |
TESTOSTERONE | TESTOSTERONE | 25MG/2.5GM PACKET | GEL;TRANSDERMAL | Discontinued | None | No | No |
TESTOSTERONE | TESTOSTERONE | 50MG/5GM PACKET | GEL;TRANSDERMAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
01/31/2013 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203098s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203098Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203098Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203098Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/25/2016 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203098s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203098Orig1s009ltr.pdf | |
02/26/2016 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/11/2015 | SUPPL-6 | Labeling-Package Insert, REMS-Modified, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203098s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203098Orig1s006ltr.pdf | |
02/03/2015 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/19/2014 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203098s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203098Orig1s002ltr.pdf | |
05/01/2015 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/25/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203098s009lbl.pdf | |
05/11/2015 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203098s006lbl.pdf | |
05/11/2015 | SUPPL-6 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203098s006lbl.pdf | |
05/11/2015 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203098s006lbl.pdf | |
06/19/2014 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203098s002lbl.pdf | |
01/31/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203098s000lbl.pdf |