Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074467
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription AB No No
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription AB 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
08/29/1997 ORIG-1 Approval Review
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074467_ranitidine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/074467.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/07/2013 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

05/27/2009 SUPPL-35 Labeling

Label is not available on this site.

12/26/2007 SUPPL-30 Labeling

Label is not available on this site.

04/28/2005 SUPPL-28 Labeling

Label is not available on this site.

11/05/2002 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/2000 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/30/2000 SUPPL-20 Labeling

Label is not available on this site.

11/30/2000 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/2000 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/2000 SUPPL-16 Labeling

Label is not available on this site.

03/08/2000 SUPPL-15 Labeling

Label is not available on this site.

11/09/2000 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/18/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/18/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/18/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/18/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/18/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/23/1999 SUPPL-5 Labeling

Label is not available on this site.

04/23/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/08/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/17/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/17/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

RANITIDINE HYDROCHLORIDE

TABLET;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 TABLET;ORAL Prescription No AB 203694 ACIC PHARMS
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 077824 AMNEAL PHARMS NY
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 074680 APOTEX
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 076705 DR REDDYS LABS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 078542 GLENMARK PHARMS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 075165 HERITAGE PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 075180 PAR PHARM
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 074467 SANDOZ
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 205512 STRIDES PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 210010 STRIDES PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 074488 TEVA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 211289 VKT PHARMA PVT LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 075208 WOCKHARDT LTD

TABLET;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 TABLET;ORAL Prescription No AB 203694 ACIC PHARMS
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 077824 AMNEAL PHARMS NY
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 074680 APOTEX
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 076705 DR REDDYS LABS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 078542 GLENMARK PHARMS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 075165 HERITAGE PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 075180 PAR PHARM
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 074467 SANDOZ
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 205512 STRIDES PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 210010 STRIDES PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 074488 TEVA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 211289 VKT PHARMA PVT LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 075208 WOCKHARDT LTD

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