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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018299
Company: MONARCH PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIROPTIC TRIFLURIDINE 1% SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes 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
04/10/1980 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/19/2018 SUPPL-16 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

02/20/2002 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18299s014ltr.pdf
02/10/1997 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/31/1996 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1996 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/17/1997 SUPPL-9 Labeling

Label is not available on this site.

05/08/1995 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1991 SUPPL-6 Labeling

Label is not available on this site.

12/05/1988 SUPPL-5 Labeling

Label is not available on this site.

03/14/1983 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/1981 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/30/1980 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/27/1980 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

VIROPTIC

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 074311 SANDOZ INC
VIROPTIC TRIFLURIDINE 1% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 018299 MONARCH PHARMS
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