Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077600
Company: RUBICON
Company: RUBICON
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 |
---|---|---|---|---|---|---|---|
11/13/2008 | 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 |
---|---|---|---|---|---|
12/14/2014 | SUPPL-2 | Labeling-Package Insert |
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 | 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 PHARMA |
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 |