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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074311
Company: SANDOZ

Products on ANDA 074311

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIFLURIDINE	TRIFLURIDINE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074311

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.

Therapeutic Equivalents for ANDA 074311

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

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