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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078031
Company: SANDOZ

Products on ANDA 078031

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078031

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/06/2008	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 078031

DICLOFENAC SODIUM

SOLUTION/DROPS;OPHTHALMIC; 0.1%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICLOFENAC SODIUM	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	203383	ALTAIRE PHARMS INC
DICLOFENAC SODIUM	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078792	BAUSCH AND LOMB
DICLOFENAC SODIUM	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078553	RISING
DICLOFENAC SODIUM	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	077600	RUBICON
DICLOFENAC SODIUM	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078031	SANDOZ

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