Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074511
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SULSTER | PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM | EQ 0.23% PHOSPHATE;10% | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
07/30/1996 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/074511_sulster_toc.cfm |