Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008048
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XYLOCAINE LIDOCAINE 5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** OINTMENT;TOPICAL Discontinued None Yes No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
05/17/1951 ORIG-1 Approval Type 2 - New Active Ingredient 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
12/04/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/02/1996 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/31/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/18/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/11/1991 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/27/1990 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/07/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/16/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/24/1986 SUPPL-8 Labeling

Label is not available on this site.

06/15/1984 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/25/1982 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/1985 SUPPL-5 Labeling

Label is not available on this site.

06/16/1980 SUPPL-4 Labeling

Label is not available on this site.

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