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Serving 500+ biopharmaceutical companies globally:

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Generated: September 21, 2017

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Details for New Drug Application (NDA): 077991

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NDA 077991 describes CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Sun Pharm Inds Ltd, Ivax Sub Teva Pharms, and Sandoz, and is included in three NDAs. It is available from thirty-two suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.

The generic ingredient in CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for NDA: 077991

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 077991

Suppliers and Packaging for NDA: 077991

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
cetirizine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 077991 ANDA Physicians Total Care, Inc. 54868-5884 54868-5884-0 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-5884-0)
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
cetirizine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 077991 ANDA Physicians Total Care, Inc. 54868-5884 54868-5884-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-5884-1)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;120MG
Approval Date:Mar 5, 2008TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Cipla
US Army
Dow
Accenture
Deloitte
Johnson and Johnson
Healthtrust
McKinsey
Chubb

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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