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FDA Drug Approval, N208219, LOTEMAX SM
FDA Drug Approval, N208219, LOTEMAX SM
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NDA: 208219
Company: BAUSCH AND LOMB INC
Drug Name: LOTEMAX SM
Active Ingredients: LOTEPREDNOL ETABONATE
Strength: 0.38%
Dosage Form/Route: GEL;OPHTHALMIC
Action Date: 02/22/2019
Marketing Status: Prescription
Submission Classification: Type 5 - New Formulation or New Manufacturer
Company: BAUSCH AND LOMB INC
Drug Name: LOTEMAX SM
Active Ingredients: LOTEPREDNOL ETABONATE
Strength: 0.38%
Dosage Form/Route: GEL;OPHTHALMIC
Action Date: 02/22/2019
Marketing Status: Prescription
Submission Classification: Type 5 - New Formulation or New Manufacturer
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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