Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205388
Company: RAYNER SURGICAL
Company: RAYNER SURGICAL
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 | RAYNER SURGICAL |