Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074447
Company: BAUSCH AND LOMB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLURBIPROFEN SODIUM FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS;OPHTHALMIC Prescription AT 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
01/04/1995 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
01/28/2013 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

12/09/2002 SUPPL-13 Labeling

Label is not available on this site.

11/27/2001 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/30/2001 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/07/2001 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/27/2000 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/28/2000 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/18/2000 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/07/1999 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/24/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/19/1998 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/28/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/22/1998 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/08/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

FLURBIPROFEN SODIUM

SOLUTION/DROPS;OPHTHALMIC; 0.03%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLURBIPROFEN SODIUM FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 074447 BAUSCH AND LOMB
OCUFEN FLURBIPROFEN SODIUM 0.03% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 019404 ALLERGAN

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