Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020745
Company: SANOFI US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZANTAC 75 RANITIDINE HYDROCHLORIDE EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EFFERVESCENT;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/26/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/08/1999 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

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