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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020021

SUDAFED 24 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE)
240MG
Marketing Status: Over-the-counter
Active Ingredient: PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: SUDAFED 24 HOUR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 240MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020021
Product Number: 002
Approval Date: Dec 15, 1992
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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