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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207466

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METAXALONE (METAXALONE)
400MG
Marketing Status: Prescription
Active Ingredient: METAXALONE
Proprietary Name: METAXALONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207466
Product Number: 002
Approval Date: Mar 13, 2020
Applicant Holder Full Name: SCIEGEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
METAXALONE (METAXALONE)
800MG
Marketing Status: Prescription
Active Ingredient: METAXALONE
Proprietary Name: METAXALONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 800MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207466
Product Number: 001
Approval Date: Aug 31, 2017
Applicant Holder Full Name: SCIEGEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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