➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKesson
Dow
Harvard Business School
McKinsey
Express Scripts
Baxter

Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210622


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 210622 describes CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Athem, Aurobindo Pharma, Cypress Pharm, Hetero Labs Ltd Iii, Lannett Co Inc, Perrigo R And D, Pharm Assoc, Quagen, Ranbaxy Labs Ltd, Taro, Torrent, Tris Pharma Inc, Jubilant Generics, Novel Labs Inc, Sandoz, and Sun Pharm, and is included in twenty NDAs. It is available from fifty-one suppliers. Additional details are available on the CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY profile page.

The generic ingredient in CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and thirty-three suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 210622
Tradename:CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
Applicant:Hetero Labs Ltd Iii
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 210622
Suppliers and Packaging for NDA: 210622
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 210622 ANDA A-S Medication Solutions 50090-4741 50090-4741-0 1 BOTTLE in 1 CARTON (50090-4741-0) > 118 mL in 1 BOTTLE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 210622 ANDA Camber Consumer Care 69230-316 69230-316-11 1 BOTTLE in 1 CARTON (69230-316-11) > 118 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Mar 13, 2019TE:RLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Medtronic
Moodys
Dow
McKinsey

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 verification 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.