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Last Updated: March 28, 2024

Ranitidine - Generic Drug Details


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Recent Clinical Trials for ranitidine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Menoufia UniversityPhase 2/Phase 3
Cairo UniversityN/A
University of Sao Paulo General HospitalPhase 3

See all ranitidine clinical trials

Generic filers with tentative approvals for RANITIDINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial15MG/MLSolution; Oral

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for ranitidine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Strides Pharma RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 209160-001 Mar 5, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms RANITIDINE HYDROCHLORIDE ranitidine hydrochloride SYRUP;ORAL 078312-001 Sep 2, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nostrum Labs Inc RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 203694-002 Nov 30, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pai Holdings Pharm ZANTAC ranitidine hydrochloride INJECTABLE;INJECTION 019090-001 Oct 19, 1984 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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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.