Drugs@FDA: FDA Approved Drug Products
New Drug Application (NDA): 202763
Company: ANI PHARMS INC
Company: ANI PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| 02/14/2012 | 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/2012/202763s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202763s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202763Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202763Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/25/2016 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202763s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202763Orig1s004ltr.pdf | |
| 05/11/2015 | SUPPL-3 | Labeling-Package Insert, REMS-Modified, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202763s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202763Orig1s003ltr.pdf | |
| 06/19/2014 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202763s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202763Orig1s002ltr.pdf | |
| 07/23/2014 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202763s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202763Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/25/2016 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202763s004lbl.pdf | |
| 05/11/2015 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202763s003lbl.pdf | |
| 05/11/2015 | SUPPL-3 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202763s003lbl.pdf | |
| 05/11/2015 | SUPPL-3 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202763s003lbl.pdf | |
| 07/23/2014 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202763s001lbl.pdf | |
| 06/19/2014 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202763s002lbl.pdf | |
| 02/14/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202763s000lbl.pdf |
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