Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020589

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CHILDREN'S ADVIL (IBUPROFEN)
100MG/5ML Marketing Status: Over-the-counter

Active Ingredient: IBUPROFEN
Proprietary Name: CHILDREN'S ADVIL
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 100MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020589
Product Number: 001
Approval Date: Jun 27, 1996
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

CHILDREN'S ADVIL-FLAVORED (IBUPROFEN)
100MG/5ML Marketing Status: Over-the-counter

Active Ingredient: IBUPROFEN
Proprietary Name: CHILDREN'S ADVIL-FLAVORED
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 100MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020589
Product Number: 002
Approval Date: Nov 7, 1997
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

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