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Details for New Drug Application (NDA): 018989

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NDA 018989 describes ADVIL, which is a drug marketed by Pfizer Cons Hlthcare and Pfizer and is included in ten NDAs. It is available from three suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ADVIL profile page.

The generic ingredient in ADVIL is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.

Summary for NDA: 018989

Tradename:
ADVIL
Applicant:
Pfizer
Ingredient:
ibuprofen
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 018989

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVIL
ibuprofen
TABLET;ORAL 018989 NDA Pfizer Consumer Healthcare 0573-0150 0573-0150-20 1 BOTTLE in 1 CARTON (0573-0150-20) > 24 TABLET, COATED in 1 BOTTLE
ADVIL
ibuprofen
TABLET;ORAL 018989 NDA Pfizer Consumer Healthcare 0573-0150 0573-0150-30 1 BOTTLE in 1 CARTON (0573-0150-30) > 50 TABLET, COATED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG
Approval Date:May 18, 1984TE:RLD:No


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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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