Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013334
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DECADRON W/ XYLOCAINE DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE EQ 4MG PHOSPHATE/ML;10MG/ML INJECTABLE;INJECTION 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
07/11/1962 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
03/01/1996 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/27/1993 SUPPL-32 Labeling

Label is not available on this site.

02/12/1991 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/08/1985 SUPPL-23 Labeling

Label is not available on this site.

02/21/1983 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/04/1982 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1982 SUPPL-18 Labeling

Label is not available on this site.

07/13/1979 SUPPL-17 Labeling

Label is not available on this site.

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