FDA Drug Approval, A212025, APOMORPHINE HYDROCHLORIDE
FDA Drug Approval, A212025, APOMORPHINE HYDROCHLORIDE
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Contents: CMC section from the Summary Basis of Approval; Clinical Review Summary; and Review Package including any evaluation of the product.
ANDA: 212025
Company: SAGE CHEMS
Drug Name: APOMORPHINE HYDROCHLORIDE
Active Ingredients: APOMORPHINE HYDROCHLORIDE
Strength: 30MG/3ML (10MG/ML)
Dosage Form/Route: INJECTABLE;SUBCUTANEOUS
Action Date: 02/23/2022
Marketing Status: Prescription
Submission Classification: ORIG-1 TE Code: AP
- 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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