HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Zyrtec-D Paragraph IV Application Submitted To FDA

This article was originally published in The Tan Sheet

Executive Summary

A generic version of Pfizer's Zyrtec-D 12 Hour is among the Paragraph IV abbreviated new drug applications submitted to FDA early this summer

You may also be interested in...

Orally Dissolving Strips To Melt Away Heartburn? ANDA Suitability Sought

An orally disintegrating strip form of Johnson & Johnson/Merck's Pepcid AC (famotidine 10 mg) could be heading towards the market if FDA looks favorably upon a pending ANDA suitability petition

Sanofi-Aventis Combo Leaves Allegra In Rx Territory For Now

Allegra's status as a prescription-only drug appears to be secure in the near-term now that Aventis has accepted Sanofi-Synthelabo's sweetened hostile bid for the company

Commit Lozenge Generic Equivalent Application Filed

A recent regulatory submission filed with FDA is seeking 180-day exclusivity for a generic version of nicotine replacement therapy lozenges

Related Content





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts