Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203502

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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: A203502
Product Number: 001
Approval Date: Aug 31, 2015
Applicant Holder Full Name: AUROLIFE PHARMA LLC
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: A203502
Product Number: 002
Approval Date: Aug 31, 2015
Applicant Holder Full Name: AUROLIFE PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information