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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Harvard Business School
Fish and Richardson

Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073585

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NDA 073585 describes SUDAFED 12 HOUR, which is a drug marketed by Glaxosmithkline and Mcneil Cons and is included in two NDAs. It is available from two suppliers. Additional details are available on the SUDAFED 12 HOUR profile page.

The generic ingredient in SUDAFED 12 HOUR is pseudoephedrine hydrochloride. There are forty-nine drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the pseudoephedrine hydrochloride profile page.
Summary for 073585
Tradename:SUDAFED 12 HOUR
Applicant:Mcneil Cons
Ingredient:pseudoephedrine hydrochloride
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 073585
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUDAFED 12 HOUR pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 073585 ANDA A-S Medication Solutions 50090-1106 N 50090-1106-0
SUDAFED 12 HOUR pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 073585 ANDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-670 N 50580-670-10

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Oct 31, 1991TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
US Army
Queensland Health

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