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General MedicationsIRRIGATIONStandard

KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE

KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

Standard Dose
EQ 0.3% BASE;EQ 1% BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription

Key Takeaways

  • Primary indication: Review priority: STANDARD Marketing status: Prescription
  • Approval overview KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE is listed in Drugs@FDA under application 210183 (ANDA).
  • Review priority: STANDARD Marketing status: Prescription Active ingredient KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE Form and strength SOLUTION;IRRIGATION - EQ 0.3% BASE;EQ 1% BASE Sponsor LUPIN LTD Submission history Latest submission status date: 2019-07-01 00:00:00.

Structured Monograph

Clinical summary

Approval overview KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE is listed in Drugs@FDA under application 210183 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE Form and strength SOLUTION;IRRIGATION - EQ 0.3% BASE;EQ 1% BASE Sponsor LUPIN LTD Submission history Latest submission status date: 2019-07-01 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.