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Last Updated: July 27, 2024

Ranitidine - Generic Drug Details


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Recent Clinical Trials for ranitidine

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

SponsorPhase
Kasr El Aini HospitalN/A
Menoufia UniversityPhase 2/Phase 3
Cairo UniversityN/A

See all ranitidine clinical trials

Generic filers with tentative approvals for RANITIDINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up15MG/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
Sandoz RANITIDINE HYDROCHLORIDE ranitidine hydrochloride CAPSULE;ORAL 074655-001 Oct 22, 1997 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Ltd RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 075439-002 Apr 19, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 074467-001 Aug 29, 1997 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chattem Sanofi ZANTAC 150 ranitidine hydrochloride TABLET;ORAL 021698-001 Aug 31, 2004 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Ltd RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 075132-001 Jan 14, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ranbaxy RANITIDINE HYDROCHLORIDE ranitidine hydrochloride TABLET;ORAL 075000-001 Jan 30, 1998 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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