Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040069
Company: BAUSCH AND LOMB
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 Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/26/1996 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
12/23/2002 SUPPL-15 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

11/27/2001 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/30/2001 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/07/2001 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/27/2000 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/28/2000 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/18/2000 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/07/1999 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/27/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/19/1998 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/10/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/13/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/16/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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