Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078553
Company: RISING
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/28/2007 ORIG-1 Approval

Label is not available on this site.

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 077845 AKORN
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 078031 SANDOZ INC
VOLTAREN DICLOFENAC SODIUM 0.1% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 020037 NOVARTIS

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