Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021623
Company: GALEN SPECIALTY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYNERA LIDOCAINE; TETRACAINE 70MG;70MG PATCH;TOPICAL Prescription None Yes Yes
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
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
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

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