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FDA ANDA · ANDA210183

KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE

Sponsor: LUPIN

APPLICATION
ANDA210183
TYPE
ANDA
ORIGINAL APPROVAL
2019-07-01
LATEST ACTION
2019-07-01
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDEPrescription
KETOROLAC TROMETHAMINE EQ 0.3% BASE, PHENYLEPHRINE HYDROCHLORIDE EQ 1% BASE · SOLUTION · IRRIGATION

Approval history

2019-07-01UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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