Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088771
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 0.1% PHOSPHATE SOLUTION/DROPS;OPHTHALMIC, OTIC 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
01/16/1985 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
03/06/2009 SUPPL-24 Labeling

Label is not available on this site.

04/11/2005 SUPPL-22 Labeling

Label is not available on this site.

05/10/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/19/1999 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/29/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

12/15/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/16/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/26/1995 SUPPL-9 Labeling

Label is not available on this site.

02/08/1994 SUPPL-8 Labeling

Label is not available on this site.

02/08/1994 SUPPL-7 Labeling

Label is not available on this site.

09/19/1991 SUPPL-6 Labeling

Label is not available on this site.

08/03/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/03/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/14/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/02/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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