Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088469
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/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
01/25/1984 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/08/1994 SUPPL-12 Labeling

Label is not available on this site.

07/02/1993 SUPPL-10 Labeling

Label is not available on this site.

12/03/1991 SUPPL-9 Labeling

Label is not available on this site.

08/07/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/30/1991 SUPPL-7 Labeling

Label is not available on this site.

05/16/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/18/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/10/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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