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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211228

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METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE)
5MG
Marketing Status: Prescription
Active Ingredient: METHADONE HYDROCHLORIDE
Proprietary Name: METHADONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A211228
Product Number: 001
Approval Date: Jan 3, 2019
Applicant Holder Full Name: ASCENT PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE)
10MG
Marketing Status: Prescription
Active Ingredient: METHADONE HYDROCHLORIDE
Proprietary Name: METHADONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A211228
Product Number: 002
Approval Date: Jan 3, 2019
Applicant Holder Full Name: ASCENT PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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