Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040067
Company: BAUSCH AND LOMB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TROPICAMIDE TROPICAMIDE 0.5% 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
07/27/1994 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
11/13/2015 SUPPL-24 Labeling-Package Insert

Label is not available on this site.
11/27/2001 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
03/07/2001 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
10/05/2000 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.
05/15/2000 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
04/28/2000 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
05/18/2000 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
06/07/1999 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
11/19/1998 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
06/02/2000 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
03/12/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
01/22/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

TROPICAMIDE

SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MYDRIACYL TROPICAMIDE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 084305 SANDOZ INC
TROPICACYL TROPICAMIDE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 040314 AKORN
TROPICAMIDE TROPICAMIDE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 040067 BAUSCH AND LOMB

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