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Details for New Drug Application (NDA): 020589

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NDA 020589 describes CHILDREN'S ADVIL-FLAVORED, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. Additional details are available on the CHILDREN'S ADVIL-FLAVORED profile page.

The generic ingredient in CHILDREN'S ADVIL-FLAVORED is ibuprofen. There are sixty-three drug master file entries for this compound. Two hundred and fifty suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

Summary for NDA: 020589

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020589

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S ADVIL
ibuprofen
SUSPENSION;ORAL 020589 NDA Pfizer Consumer Healthcare 0573-0170 0573-0170-01 1 BOTTLE in 1 CARTON (0573-0170-01) > 30 mL in 1 BOTTLE
CHILDREN'S ADVIL
ibuprofen
SUSPENSION;ORAL 020589 NDA Pfizer Consumer Healthcare 0573-0170 0573-0170-30 1 BOTTLE in 1 CARTON (0573-0170-30) > 120 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION;ORALStrength100MG/5ML
Approval Date:Jun 27, 1996TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION;ORALStrength100MG/5ML
Approval Date:Nov 7, 1997TE:RLD:No

Expired Orange Book Patents for NDA: 020589

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
CHILDREN'S ADVIL
ibuprofen
SUSPENSION;ORAL020589-001Jun 27, 19964,788,220*PED► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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