Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074311
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIFLURIDINE TRIFLURIDINE 1% 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
10/06/1995 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
12/19/2002 SUPPL-16 Labeling

Label is not available on this site.

10/01/2002 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/17/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/2001 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

04/30/2001 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/30/2001 SUPPL-11 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

04/30/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/2001 SUPPL-9 Labeling

Label is not available on this site.

02/19/1999 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/16/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/02/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/30/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/21/1996 SUPPL-1 Labeling

Label is not available on this site.

TRIFLURIDINE

SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRIFLURIDINE TRIFLURIDINE 1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 205438 HI TECH
TRIFLURIDINE TRIFLURIDINE 1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 074311 SANDOZ INC
VIROPTIC TRIFLURIDINE 1% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 018299 MONARCH PHARMS

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