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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212047

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CHLORZOXAZONE (CHLORZOXAZONE)
375MG
Marketing Status: Prescription
Active Ingredient: CHLORZOXAZONE
Proprietary Name: CHLORZOXAZONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 375MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212047
Product Number: 001
Approval Date: Jan 27, 2023
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
CHLORZOXAZONE (CHLORZOXAZONE)
750MG
Marketing Status: Prescription
Active Ingredient: CHLORZOXAZONE
Proprietary Name: CHLORZOXAZONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 750MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212047
Product Number: 002
Approval Date: Jan 27, 2023
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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