An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018299
Company: MONARCH PHARMS

Products on NDA 018299

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIROPTIC	TRIFLURIDINE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018299

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.

Therapeutic Equivalents for NDA 018299

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

Top