FDA Drug Approval, ANDA 212025, APOMORPHINE HYDROCHLORIDE

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

226 pages (32 of 258 original pages are fully redacted)