Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 014394
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XYLOCAINE LIDOCAINE 10% AEROSOL;ORAL Discontinued None No 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
04/20/1965 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
03/28/1994 SUPPL-9 Labeling

Label is not available on this site.

01/04/1985 SUPPL-2 Labeling

Label is not available on this site.

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