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FDA Drug Approval, N050777, PROTOPIC
FDA Drug Approval, N050777, PROTOPIC
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NDA: 050777
Company: LEO PHARMA AS
Drug Name: PROTOPIC
Active Ingredients: TACROLIMUS
Strength: 0.1%
Dosage Form/Route: OINTMENT;TOPICAL
Action Date: 12/08/2000
Marketing Status: Prescription
Submission Classification: Type 3 - New Dosage Form
Company: LEO PHARMA AS
Drug Name: PROTOPIC
Active Ingredients: TACROLIMUS
Strength: 0.1%
Dosage Form/Route: OINTMENT;TOPICAL
Action Date: 12/08/2000
Marketing Status: Prescription
Submission Classification: Type 3 - New Dosage Form
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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