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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021624

METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE)
10MG/ML
Marketing Status: Prescription
Active Ingredient: METHADONE HYDROCHLORIDE
Proprietary Name: METHADONE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021624
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MYLAN INSTITUTIONAL LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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