Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022309
Company: BESINS HLTHCARE
Company: BESINS HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANDROGEL | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | AB | Yes | Yes |
| ANDROGEL | TESTOSTERONE | 1.62% (20.25MG/1.25GM PACKET) | GEL;TRANSDERMAL | Prescription | AB2 | Yes | No |
| ANDROGEL | TESTOSTERONE | 1.62% (40.5MG/2.5GM PACKET) | GEL;TRANSDERMAL | Prescription | AB2 | 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 |
|---|---|---|---|---|---|---|---|
| 04/29/2011 | 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/2011/022309s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022309s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022309_androgel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022309Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/30/2019 | SUPPL-21 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022309Orig1s021ltr.pdf |
| 05/10/2019 | SUPPL-20 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022309s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022309Orig1s020ltr.pdf | |
| 02/25/2019 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022309s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022309Orig1s018ltr.pdf | |
| 10/25/2016 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022309s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022309Orig1s017ltr.pdf | |
| 08/17/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/2015 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022309s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022309Orig1s014ltr.pdf | |
| 06/11/2015 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/2014 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022309Orig1s012ltr.pdf | |
| 11/14/2014 | SUPPL-11 | Labeling-Package Insert, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022309Orig1s011ltr.pdf | |
| 02/28/2014 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/2013 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022309s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022309Orig1s008ltr.pdf | |
| 03/12/2013 | SUPPL-7 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022309Orig1s007ltr.pdf |
| 03/13/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/2012 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/2012 | SUPPL-1 | Labeling-Container/Carton Labels, REMS-Modified |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022309s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022309Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022309Orig1s001.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/10/2019 | SUPPL-20 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022309s020lbl.pdf | |
| 02/25/2019 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022309s008lbl.pdf | |
| 10/25/2016 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022309s017lbl.pdf | |
| 05/11/2015 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022309s014lbl.pdf | |
| 05/11/2015 | SUPPL-14 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022309s014lbl.pdf | |
| 05/11/2015 | SUPPL-14 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022309s014lbl.pdf | |
| 11/14/2014 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s011lbl.pdf | |
| 11/14/2014 | SUPPL-11 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s011lbl.pdf | |
| 06/19/2014 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s012lbl.pdf | |
| 05/20/2013 | SUPPL-8 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022309s008lbl.pdf | |
| 05/20/2013 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022309s008lbl.pdf | |
| 09/07/2012 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022309s001lbl.pdf | |
| 09/07/2012 | SUPPL-1 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022309s001lbl.pdf | |
| 04/29/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022309s000lbl.pdf |
ANDROGEL
GEL, METERED;TRANSDERMAL; 1.62% (20.25MG/1.25GM ACTUATION)
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ANDROGEL | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | Yes | AB | 022309 | BESINS HLTHCARE |
| TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | No | AB | 204570 | ACTAVIS LABS UT INC |
| TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | No | AB | 207373 | AMNEAL |
| TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | No | AB | 208620 | ENCUBE |
| TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | No | AB | 208560 | LUPIN |
| TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | No | AB | 204268 | PADAGIS ISRAEL |
| TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | No | AB | 209390 | TWI PHARMS |
| TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | No | AB | 210835 | XIROMED |
GEL;TRANSDERMAL; 1.62% (20.25MG/1.25GM PACKET)
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ANDROGEL | TESTOSTERONE | 1.62% (20.25MG/1.25GM PACKET) | GEL;TRANSDERMAL | Prescription | Yes | AB2 | 022309 | BESINS HLTHCARE |
| TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM PACKET) | GEL;TRANSDERMAL | Prescription | No | AB2 | 204570 | ACTAVIS LABS UT INC |
| TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM PACKET) | GEL;TRANSDERMAL | Prescription | No | AB2 | 205781 | PADAGIS ISRAEL |
GEL;TRANSDERMAL; 1.62% (40.5MG/2.5GM PACKET)
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ANDROGEL | TESTOSTERONE | 1.62% (40.5MG/2.5GM PACKET) | GEL;TRANSDERMAL | Prescription | Yes | AB2 | 022309 | BESINS HLTHCARE |
| TESTOSTERONE | TESTOSTERONE | 1.62% (40.5MG/2.5GM PACKET) | GEL;TRANSDERMAL | Prescription | No | AB2 | 204570 | ACTAVIS LABS UT INC |
| TESTOSTERONE | TESTOSTERONE | 1.62% (40.5MG/2.5GM PACKET) | GEL;TRANSDERMAL | Prescription | No | AB2 | 205781 | PADAGIS ISRAEL |