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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008816
Company: EPIC PHARMA LLC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XYLOCAINE LIDOCAINE HYDROCHLORIDE 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JELLY;TOPICAL Discontinued None Yes No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
03/12/1953 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2018 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008816s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008816Orig1s039Ltr.pdf
10/24/2013 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.
09/24/2013 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.
11/28/2012 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.
07/23/2004 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08816s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/08816s032ltr.pdf
06/02/2000 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/29/1999 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/31/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
04/07/1998 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/18/1993 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
11/07/1990 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/08/1987 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/08/1987 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
09/16/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
06/20/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
07/11/1984 SUPPL-13 Labeling

Label is not available on this site.
07/11/1984 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.
03/25/1982 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
11/20/1984 SUPPL-8 Labeling

Label is not available on this site.
02/23/1981 SUPPL-7 Labeling

Label is not available on this site.
02/23/1981 SUPPL-6 Efficacy

Label is not available on this site.
02/16/1979 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/02/1977 SUPPL-4 Labeling

Label is not available on this site.
01/12/1977 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
02/02/1977 SUPPL-2 Labeling

Label is not available on this site.
03/06/1973 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/02/2018 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008816s039lbl.pdf
07/23/2004 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/08816s032lbl.pdf
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