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Generated: August 19, 2017

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 one supplier. 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-four suppliers are listed for this compound. Additional details are available on the pseudoephedrine hydrochloride profile page.

Summary for NDA: 073585

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
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 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-670 50580-670-10 1 BLISTER PACK in 1 CARTON (50580-670-10) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
SUDAFED 12 HOUR
pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 073585 ANDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-670 50580-670-20 2 BLISTER PACK in 1 CARTON (50580-670-20) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Summary 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 500+ biopharmaceutical companies globally:

McKinsey
US Department of Justice
Boehringer Ingelheim
Colorcon
Citi
Fish and Richardson
Covington
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