Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Baxter
Medtronic
Express Scripts
Merck

Last Updated: December 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205136

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

NDA 205136 describes MECLIZINE HYDROCHLORIDE, which is a drug marketed by Ivax Sub Teva Pharms, Nexgen Pharma Inc, Pliva, Abc Holding, Amneal Pharms, Anabolic, Anda Repository, Ani Pharms Inc, Bundy, Epic Pharma Llc, Indicus Pharma, Jubilant Cadista, Kv Pharm, Mylan Pharms Inc, Par Pharm, Sandoz, Superpharm, UDL, Vangard, and Watson Labs, and is included in thirty-four NDAs. It is available from thirty-five suppliers. Additional details are available on the MECLIZINE HYDROCHLORIDE profile page.

The generic ingredient in MECLIZINE HYDROCHLORIDE is meclizine hydrochloride. There are seventeen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the meclizine hydrochloride profile page.
Summary for 205136
Tradename:MECLIZINE HYDROCHLORIDE
Applicant:Indicus Pharma
Ingredient:meclizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205136
Physiological EffectEmesis Suppression
Medical Subject Heading (MeSH) Categories for 205136
Suppliers and Packaging for NDA: 205136
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 205136 ANDA Wilshire Pharmaceuticals Inc 52536-129 52536-129-01 100 TABLET in 1 BOTTLE (52536-129-01)
MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 205136 ANDA Wilshire Pharmaceuticals Inc 52536-129 52536-129-10 1000 TABLET in 1 BOTTLE (52536-129-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Feb 22, 2019TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Feb 22, 2019TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Feb 22, 2019TE:RLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
McKesson
McKinsey
Boehringer Ingelheim
Baxter

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.