Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103691
Company: SMITH AND NEPHEW
Company: SMITH AND NEPHEW
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
REGRANEX | BECAPLERMIN | 100UG/G | GEL; TOPICAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
12/16/1997 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/becaomj121697-lab.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/becaomj121697L.htm https://web.archive.org/web/20170113111514/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080740.htm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/26/2019 | SUPPL-5138 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103691s5138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103691Orig1s5138ltr.pdf | |
11/28/2018 | SUPPL-5134 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103691s5134lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103691Orig1s5134ltr.pdf | |
04/30/2012 | SUPPL-5109 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103691s5109ltr.pdf |
03/11/2011 | SUPPL-5095 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103691s5095lbl.pdf | |
04/28/2010 | SUPPL-5087 | Supplement |
Label is not available on this site. |
||
04/09/2010 | SUPPL-5086 | Supplement |
Label is not available on this site. |
||
10/16/2008 | SUPPL-5074 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103691s5074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103691s5074ltr.pdf | |
05/13/2005 | SUPPL-5015 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103691s5015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103691s5015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/103691Orig1s5015Approv.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/26/2019 | SUPPL-5138 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103691s5138lbl.pdf | |
11/28/2018 | SUPPL-5134 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103691s5134lbl.pdf | |
03/11/2011 | SUPPL-5095 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103691s5095lbl.pdf | |
10/16/2008 | SUPPL-5074 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103691s5074lbl.pdf | |
05/13/2005 | SUPPL-5015 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103691s5015lbl.pdf | |
12/16/1997 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/becaomj121697-lab.pdf |