Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084305
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYDRIACYL TROPICAMIDE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription AT 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
12/06/1974 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
10/31/2003 SUPPL-31 Labeling

Label is not available on this site.

12/23/2002 SUPPL-30 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/07/2000 SUPPL-29 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

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

Label is not available on this site.

04/21/1999 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/11/2000 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/23/1999 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/07/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/16/2000 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/04/1999 SUPPL-21 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/25/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/22/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/05/1995 SUPPL-18 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/04/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/14/1993 SUPPL-16 Labeling

Label is not available on this site.

11/05/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/04/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/07/1997 SUPPL-13 Labeling

Label is not available on this site.

06/04/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/26/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/03/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/13/1984 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/12/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

MYDRIACYL

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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