Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Check market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205352

« Back to Dashboard
NDA 205352 describes ALEVE PM, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the ALEVE PM profile page.

The generic ingredient in ALEVE PM is diphenhydramine hydrochloride; naproxen sodium. There are twenty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the diphenhydramine hydrochloride; naproxen sodium profile page.

Summary for NDA: 205352

Bayer Hlthcare
diphenhydramine hydrochloride; naproxen sodium
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 205352

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
diphenhydramine hydrochloride; naproxen sodium
TABLET;ORAL 205352 NDA Bayer HealthCare Consumer Care 0280-1200 0280-1200-02 2 TABLET, FILM COATED in 1 POUCH (0280-1200-02)
diphenhydramine hydrochloride; naproxen sodium
TABLET;ORAL 205352 NDA Bayer HealthCare Consumer Care 0280-1200 0280-1200-20 1 BOTTLE in 1 CARTON (0280-1200-20) > 20 TABLET, FILM COATED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength25MG;220MG
Approval Date:Jan 17, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 17, 2017
Regulatory Exclusivity Use:NEW COMBINATION

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.