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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075180
Company: PAR PHARM

Products on ANDA 075180

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 075180

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75180ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2007	SUPPL-14	Labeling		Label is not available on this site.
10/31/2006	SUPPL-11	Labeling		Label is not available on this site.
07/15/2002	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
04/04/2003	SUPPL-5	Labeling		Label is not available on this site.
01/18/2001	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075180

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	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	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	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	211289	VKT PHARMA

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