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

Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
Covington
Julphar
UBS
AstraZeneca
Teva
Merck
Federal Trade Commission
Daiichi Sankyo

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205512

« Back to Dashboard

NDA 205512 describes RANITIDINE HYDROCHLORIDE, which is a drug marketed by Dr Reddys Labs Ltd, Mylan, Sandoz, Teva, Bedford, Mylan Labs Ltd, West-ward Pharms Int, Zydus Pharms Usa Inc, Actavis Mid Atlantic, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Bio Pharm Inc, Breckenridge Pharm, Hi Tech Pharma, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Silarx, Taro, Tolmar, Vintage Pharms, Wockhardt, Acic Pharms, Amneal Pharms Ny, Apotex, Boehringer Ingelheim, Contract Pharmacal, Dr Reddys Labs Inc, Glenmark Pharms Inc, Ivax Sub Teva Pharms, Par Pharm, Perrigo, Perrigo R And D, Strides Pharma, Sun Pharm Inds Ltd, Watson Labs, Watson Labs Inc, and Wockhardt Ltd, and is included in sixty-four NDAs. It is available from one hundred and thirty-six suppliers. Additional details are available on the RANITIDINE HYDROCHLORIDE profile page.

The generic ingredient in RANITIDINE HYDROCHLORIDE is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. One hundred and forty-three suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
Summary for 205512
Tradename:RANITIDINE HYDROCHLORIDE
Applicant:Strides Pharma
Ingredient:ranitidine hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205512
Suppliers and Packaging for NDA: 205512
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 205512 ANDA Clinical Solutions Wholesale, LLC 58118-0803 N 58118-0803-8
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 205512 ANDA Proficient Rx LP 63187-855 N 63187-855-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Aug 22, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Aug 22, 2016TE:ABRLD:No

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
McKesson
Cipla
QuintilesIMS
Fuji
Federal Trade Commission
Accenture
Baxter
Daiichi Sankyo

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.

botpot