Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075742
Company: DR REDDYS LABS LTD

Products on ANDA 075742

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075742

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75742ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075742

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	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	075742	DR REDDYS LABS LTD
RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	CAPSULE;ORAL	Prescription	No	AB	074655	SANDOZ