Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020812

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INFANT'S ADVIL (IBUPROFEN)
50MG/1.25ML
Marketing Status: Over-the-counter

Active Ingredient: IBUPROFEN
Proprietary Name: INFANT'S ADVIL
Dosage Form; Route of Administration: SUSPENSION/DROPS; ORAL
Strength: 50MG/1.25ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020812
Product Number: 002
Approval Date: Jan 12, 2000
Applicant Holder Full Name: HALEON US HOLDINGS LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

PEDIATRIC ADVIL (IBUPROFEN)
100MG/2.5ML
Marketing Status: Discontinued

Active Ingredient: IBUPROFEN
Proprietary Name: PEDIATRIC ADVIL
Dosage Form; Route of Administration: SUSPENSION/DROPS; ORAL
Strength: 100MG/2.5ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020812
Product Number: 001
Approval Date: Jan 30, 1998
Applicant Holder Full Name: HALEON US HOLDINGS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information