Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022113

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ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE)
4MG;200MG;10MG
Marketing Status: Over-the-counter

Active Ingredient: CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: ADVIL ALLERGY AND CONGESTION RELIEF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG;200MG;10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022113
Product Number: 001
Approval Date: Dec 21, 2011
Applicant Holder Full Name: HALEON US HOLDINGS LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

ADVIL MULTI-SYMPTOM COLD & FLU (CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE)
4MG;200MG;10MG
Marketing Status: Over-the-counter

Active Ingredient: CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: ADVIL MULTI-SYMPTOM COLD & FLU
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG;200MG;10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022113
Product Number: 002
Approval Date: Apr 28, 2017
Applicant Holder Full Name: HALEON US HOLDINGS LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information