Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 014127
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XYLOCAINE LIDOCAINE 5% SOLUTION;TOPICAL 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
03/11/1964 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
05/31/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/18/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/16/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/20/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/25/1982 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1985 SUPPL-2 Labeling

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English