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Generated: November 16, 2018

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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. Eleven 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
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. 0280-0270 0280-0270-20 4 BLISTER PACK in 1 CARTON (0280-0270-20) > 5 TABLET in 1 BLISTER PACK
ALEVE naproxen sodium TABLET;ORAL 020204 NDA Bayer HealthCare LLC. 0280-6000 0280-6000-02 1 BOTTLE in 1 CARTON (0280-6000-02) > 200 TABLET in 1 BOTTLE

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Jan 11, 1994TE:RLD:Yes

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