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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 020204


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NDA 020204 describes ALEVE, which is a drug marketed by Bayer and Bayer Hlthcare and is included in three NDAs. It is available from eight suppliers. Additional details are available on the ALEVE profile page.

The generic ingredient in ALEVE is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 020204
Tradename:ALEVE
Applicant:Bayer
Ingredient:naproxen sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020204
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 020204
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALEVE naproxen sodium TABLET;ORAL 020204 NDA Bayer HealthCare LLC 0280-0041 0280-0041-01 1 BOTTLE in 1 CARTON (0280-0041-01) / 175 TABLET in 1 BOTTLE
ALEVE naproxen sodium TABLET;ORAL 020204 NDA Bayer HealthCare LLC 0280-0041 0280-0041-02 1 BOTTLE in 1 CARTON (0280-0041-02) / 50 TABLET in 1 BOTTLE

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength220MG
Approval Date:Jan 11, 1994TE:RLD:Yes

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