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Generated: May 26, 2017

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Details for New Drug Application (NDA): 019771

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NDA 019771 describes ADVIL COLD AND SINUS, which is a drug marketed by Pfizer and is included in two NDAs. It is available from two suppliers. Additional details are available on the ADVIL COLD AND SINUS profile page.

The generic ingredient in ADVIL COLD AND SINUS is ibuprofen; pseudoephedrine hydrochloride. There are sixty-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.

Summary for NDA: 019771

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 019771

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVIL COLD AND SINUS
ibuprofen; pseudoephedrine hydrochloride
TABLET;ORAL 019771 NDA Pfizer Consumer Healthcare 0573-0180 0573-0180-10 2 BLISTER PACK in 1 CARTON (0573-0180-10) > 10 TABLET, COATED in 1 BLISTER PACK
ADVIL COLD AND SINUS
ibuprofen; pseudoephedrine hydrochloride
TABLET;ORAL 019771 NDA Pfizer Consumer Healthcare 0573-0180 0573-0180-21 4 BLISTER PACK in 1 CARTON (0573-0180-21) > 10 TABLET, COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG;30MG
Approval Date:Sep 19, 1989TE:RLD:Yes

Expired Orange Book Patents for NDA: 019771

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
ADVIL COLD AND SINUS
ibuprofen; pseudoephedrine hydrochloride
TABLET;ORAL019771-001Sep 19, 19894,552,899*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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