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Drugs@FDA: FDA-Approved Drugs

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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-Package Insert, Labeling-Container/Carton Labels		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

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