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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202376
Company: TORRENT

Products on ANDA 202376

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 202376

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.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/02/2022	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
09/14/2021	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/30/2018	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/30/2018	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
11/30/2018	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
11/30/2018	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/02/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/02/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202376

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	WOODWARD
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
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
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	202376	TORRENT

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