Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210183
Company: LUPIN LTD

Products on ANDA 210183

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE	KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE	EQ 0.3% BASE;EQ 1% BASE	SOLUTION;IRRIGATION	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210183

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/01/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210183Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 210183

KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE

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