Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 021128

CHILDREN'S MOTRIN COLD (IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE)
100MG/5ML;15MG/5ML Marketing Status: Over-the-counter

Active Ingredient: IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S MOTRIN COLD
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 100MG/5ML;15MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021128
Product Number: 001
Approval Date: Aug 1, 2000
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English