Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205388
Company: OMEROS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMIDRIA KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE EQ 0.3% BASE;EQ 1% BASE SOLUTION;IRRIGATION Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/30/2014 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205388s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205388Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205388Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205388Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/08/2017 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205388s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205388Orig1s006ltr.pdf
10/27/2016 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/08/2016 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/15/2016 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/21/2015 SUPPL-1 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205388s001lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/08/2017 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205388s006lbl.pdf
05/21/2015 SUPPL-1 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205388s001lbl.pdf
05/30/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205388s000lbl.pdf

OMIDRIA

SOLUTION;IRRIGATION; EQ 0.3% BASE;EQ 1% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE EQ 0.3% BASE;EQ 1% BASE SOLUTION;IRRIGATION Prescription No AT 210183 LUPIN LTD
OMIDRIA KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE EQ 0.3% BASE;EQ 1% BASE SOLUTION;IRRIGATION Prescription Yes AT 205388 OMEROS

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