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Serving leading biopharmaceutical companies globally:

Harvard Business School
Fish and Richardson
Express Scripts
Daiichi Sankyo
Johnson and Johnson
Farmers Insurance

Generated: December 14, 2017

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

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 0363-0204-69 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-69)
PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077442 ANDA Major Pharmaceuticals 0904-5803 0904-5803-15 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0904-5803-15)

Summary 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 leading biopharmaceutical companies globally:

Queensland Health
Farmers Insurance
Chinese Patent Office
Johnson and Johnson
Express Scripts

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