Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021623
Company: GALEN SPECIALTY
Company: GALEN SPECIALTY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SYNERA | LIDOCAINE; TETRACAINE | 70MG;70MG | PATCH;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
06/23/2005 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021623lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021623ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021623TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/16/2020 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021623s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021623Orig1s025ltr.pdf | |
11/02/2018 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021623s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021623Orig1s024ltr.pdf | |
01/10/2014 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/09/2013 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/16/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/10/2014 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021623s015s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021623Orig1s015,s017ltr.pdf | |
03/10/2014 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021623s015s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021623Orig1s015,s017ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/16/2020 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021623s025lbl.pdf | |
11/02/2018 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021623s024lbl.pdf | |
03/10/2014 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021623s015s017lbl.pdf | |
03/10/2014 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021623s015s017lbl.pdf | |
06/23/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021623lbl.pdf |