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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074680
Company: APOTEX

Products on ANDA 074680

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074680

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/1997	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
06/18/2012	SUPPL-16	Labeling		Label is not available on this site.
12/23/2005	SUPPL-13	Labeling		Label is not available on this site.
05/01/2000	SUPPL-3	Manufacturing (CMC)-Formulation		Label is not available on this site.
05/01/2000	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
03/24/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074680

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	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	074467	SANDOZ
RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	211289	VKT PHARMA

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	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	074467	SANDOZ
RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	211289	VKT PHARMA

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