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Details for New Drug Application (NDA): 201803

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NDA 201803 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: 201803

Tradename:
ADVIL
Applicant:
Pfizer Cons Hlthcare
Ingredient:
ibuprofen sodium
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 201803

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVIL
ibuprofen sodium
TABLET;ORAL 201803 NDA Pfizer Consumer Healthcare 0573-0133 0573-0133-02 50 PACKET in 1 TRAY (0573-0133-02) > 2 TABLET, COATED in 1 PACKET
ADVIL
ibuprofen sodium
TABLET;ORAL 201803 NDA Pfizer Consumer Healthcare 0573-0133 0573-0133-04 2 PACKET in 1 BLISTER PACK (0573-0133-04) > 2 TABLET, COATED in 1 PACKET

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Jun 12, 2012TE:RLD:Yes


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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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