Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074655
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription AB No No
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/22/1997 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/74655_Ranitidine.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/07/2013 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

05/27/2009 SUPPL-34 Labeling

Label is not available on this site.

12/26/2007 SUPPL-28 Labeling

Label is not available on this site.

04/28/2005 SUPPL-23 Labeling

Label is not available on this site.

03/12/2004 SUPPL-17 Labeling

Label is not available on this site.

04/19/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/19/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/26/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/2000 SUPPL-6 Labeling

Label is not available on this site.

03/03/2000 SUPPL-5 Labeling

Label is not available on this site.

02/02/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/20/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/20/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

RANITIDINE HYDROCHLORIDE

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 209859 AJANTA PHARMA LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 211058 AUROBINDO PHARMA LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 075742 DR REDDYS LABS LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 074655 SANDOZ

CAPSULE;ORAL; EQ 300MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 209859 AJANTA PHARMA LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 211058 AUROBINDO PHARMA LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 075742 DR REDDYS LABS LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 074655 SANDOZ

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