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Generated: November 15, 2018

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Details for New Drug Application (NDA): 020516

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NDA 020516 describes CHILDREN'S MOTRIN, which is a drug marketed by J And J Consumer Inc and is included in four NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the CHILDREN'S MOTRIN profile page.

The generic ingredient in CHILDREN'S MOTRIN is ibuprofen; pseudoephedrine hydrochloride. There are sixty-four drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.
Summary for 020516
Tradename:CHILDREN'S MOTRIN
Applicant:J And J Consumer Inc
Ingredient:ibuprofen
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020516
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S MOTRIN ibuprofen SUSPENSION;ORAL 020516 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-184 50580-184-50 1 BOTTLE, PLASTIC in 1 CARTON (50580-184-50) > 120 mL in 1 BOTTLE, PLASTIC
CHILDREN'S MOTRIN ibuprofen SUSPENSION;ORAL 020516 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-601 50580-601-08 2 CARTON in 1 PACKAGE (50580-601-08) > 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-04) > 120 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION;ORALStrength100MG/5ML
Approval Date:Jun 16, 1995TE:RLD:Yes

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