Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010496
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XYLOCAINE 5% W/ GLUCOSE 7.5% LIDOCAINE HYDROCHLORIDE 5% INJECTABLE;SPINAL 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
03/11/1958 ORIG-1 Approval Type 4 - New Combination 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
03/12/1999 SUPPL-19 Labeling

Label is not available on this site.

04/06/1995 SUPPL-18 Labeling

Label is not available on this site.

03/08/1995 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/18/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/18/1988 SUPPL-14 Labeling

Label is not available on this site.

09/16/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/28/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/25/1982 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/1985 SUPPL-10 Labeling

Label is not available on this site.

07/07/1982 SUPPL-9 Labeling

Label is not available on this site.

07/07/1982 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1979 SUPPL-7 Labeling

Label is not available on this site.

05/15/1978 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

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