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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010417
Company: FRESENIUS KABI USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XYLOCAINE 4% PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 4% INJECTABLE;INJECTION Discontinued None Yes No
XYLOCAINE 4% PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;TOPICAL Discontinued None Yes No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
05/07/1959 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/28/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
03/28/2013 SUPPL-31 Labeling-Container/Carton Labels

Label is not available on this site.
02/19/2010 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010417s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010417s027ltr.pdf
03/12/1999 SUPPL-22 Labeling

Label is not available on this site.
03/11/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
07/11/1995 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
09/13/1996 SUPPL-19 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
11/22/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
02/18/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
07/11/1989 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.
06/28/1982 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
03/25/1982 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
03/25/1985 SUPPL-11 Labeling

Label is not available on this site.
08/09/1982 SUPPL-10 Labeling

Label is not available on this site.
08/09/1982 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
11/03/1980 SUPPL-8 Labeling

Label is not available on this site.
12/04/1980 SUPPL-7 Labeling

Label is not available on this site.
12/04/1980 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.
11/03/1980 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
08/29/1979 SUPPL-4 Labeling

Label is not available on this site.
06/13/1980 SUPPL-3 Labeling

Label is not available on this site.
02/01/1973 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/19/2010 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010417s027lbl.pdf
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