Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076195
Company: PERRIGO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter None No 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
08/30/2002 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/24/2018 SUPPL-30 Labeling-Package Insert

Label is not available on this site.
02/05/2016 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

RANITIDINE HYDROCHLORIDE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; EQ 75MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 207579 AUROBINDO PHARMA LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 075294 DR REDDYS LABS LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 076195 PERRIGO
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 210250 UNIQUE PHARM LABS
ZANTAC 75 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter Yes 020520 SANOFI US

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