Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021393

ADVIL PM (DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN)
25MG;EQ 200MG FREE ACID AND POTASSIUM SALT Marketing Status: Over-the-counter

Active Ingredient: DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Proprietary Name: ADVIL PM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021393
Product Number: 001
Approval Date: Dec 21, 2005
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

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