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Generated: January 19, 2019

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Details for New Drug Application (NDA): 074937

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NDA 074937 describes CHILDREN'S IBUPROFEN, which is a drug marketed by Perrigo and is included in one NDA. It is available from forty-four suppliers. Additional details are available on the CHILDREN'S IBUPROFEN profile page.

The generic ingredient in CHILDREN'S IBUPROFEN is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and sixty-six suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
Summary for 074937
Tradename:CHILDREN'S IBUPROFEN
Applicant:Perrigo
Ingredient:ibuprofen
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 074937
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S IBUPROFEN ibuprofen SUSPENSION;ORAL 074937 ANDA L. Perrigo Company 0113-0166 0113-0166-26 1 BOTTLE in 1 CARTON (0113-0166-26) > 120 mL in 1 BOTTLE
CHILDREN'S IBUPROFEN ibuprofen SUSPENSION;ORAL 074937 ANDA L. Perrigo Company 0113-0166 0113-0166-28 1 BOTTLE in 1 CARTON (0113-0166-28) > 150 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION;ORALStrength100MG/5ML
Approval Date:Dec 22, 1998TE:RLD:No

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