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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009470
Company: FRESENIUS KABI USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XYLOCAINE VISCOUS LIDOCAINE HYDROCHLORIDE 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;ORAL Discontinued None Yes No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
09/02/1954 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
09/24/2014 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009470s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009470Orig1s025ltr.pdf
05/31/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
04/29/1996 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
04/18/1994 SUPPL-20 Labeling

Label is not available on this site.
02/18/1993 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
10/26/1993 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/14/1989 SUPPL-17 Manufacturing (CMC)-Packaging

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

Label is not available on this site.
06/20/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
03/25/1982 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
07/29/1983 SUPPL-12 Labeling

Label is not available on this site.
02/11/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
05/05/1980 SUPPL-10 Labeling

Label is not available on this site.
05/05/1980 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
12/14/1978 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
02/03/1977 SUPPL-5 Labeling

Label is not available on this site.
01/12/1977 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
05/27/1976 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.
03/05/1976 SUPPL-2 Labeling

Label is not available on this site.
05/03/1972 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
09/24/2014 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009470s025lbl.pdf
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