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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214056

ONAPGO (APOMORPHINE HYDROCHLORIDE)
98MG/20ML (4.9MG/ML)
Marketing Status: Prescription
Active Ingredient: APOMORPHINE HYDROCHLORIDE
Proprietary Name: ONAPGO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 98MG/20ML (4.9MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214056
Product Number: 001
Approval Date: Feb 3, 2025
Applicant Holder Full Name: MDD US OPERATIONS LLC A SUB OF SUPERNUS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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