Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076824
Company: DR REDDYS

Products on ANDA 076824

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076824

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/08/2013	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 076824

RABEPRAZOLE SODIUM

TABLET, DELAYED RELEASE;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACIPHEX	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	020973	WAYLIS THERAP
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	208644	ALKEM LABS LTD
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	204179	AMNEAL PHARMS
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	205761	AUROBINDO PHARMA USA
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	078964	CHARTWELL RX
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	076824	DR REDDYS
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	090678	LANNETT CO INC
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	204237	RUBICON RESEARCH
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	202376	TORRENT