Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089169
Company: DR REDDYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG 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
04/09/1986 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
12/02/2014 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

02/19/1999 SUPPL-18 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-17 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/15/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/04/1996 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/17/1995 SUPPL-14 Labeling

Label is not available on this site.

02/16/1994 SUPPL-13 Labeling

Label is not available on this site.

12/13/1993 SUPPL-12 Labeling

Label is not available on this site.

09/23/1993 SUPPL-11 Labeling

Label is not available on this site.

08/01/1988 SUPPL-8 Bioequivalence

Label is not available on this site.

08/02/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/02/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/15/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/19/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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