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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Boehringer Ingelheim
Queensland Health
US Army

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077442

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NDA 077442 describes PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, L Perrigo Co, Sun Pharm Inds Ltd, Cent Pharms, Graham Dm, Kv Pharm, and Sandoz, and is included in eight NDAs. It is available from thirty-three suppliers. Additional details are available on the PSEUDOEPHEDRINE HYDROCHLORIDE profile page.

The generic ingredient in PSEUDOEPHEDRINE HYDROCHLORIDE is pseudoephedrine hydrochloride; triprolidine hydrochloride. There are forty-nine drug master file entries for this compound. Additional details are available on the pseudoephedrine hydrochloride; triprolidine hydrochloride profile page.
Summary for 077442
Applicant:Sun Pharm Inds Ltd
Ingredient:pseudoephedrine hydrochloride
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077442
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077442 ANDA Walgreen Company 0363-0204 N 0363-0204-69
PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077442 ANDA Major Pharmaceuticals 0904-5803 N 0904-5803-15

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Sep 28, 2005TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Chinese Patent Office
Farmers Insurance
US Department of Justice
US Army

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