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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205388
Company: RAYNER SURGICAL

Summary Review

Products on NDA 205388

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205388

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

Labels for NDA 205388

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

Therapeutic Equivalents for NDA 205388

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

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