Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016297
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XYLOCAINE 1.5% W/ DEXTROSE 7.5% LIDOCAINE HYDROCHLORIDE 1.5% 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
11/04/1968 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
02/18/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/31/1988 SUPPL-11 Labeling

Label is not available on this site.

09/16/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/19/1984 SUPPL-9 Labeling

Label is not available on this site.

06/20/1984 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/25/1982 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1979 SUPPL-6 Labeling

Label is not available on this site.

05/15/1978 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/28/1977 SUPPL-3 Labeling

Label is not available on this site.

12/30/1974 SUPPL-1 Labeling

Label is not available on this site.

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