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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090678
Company: LANNETT CO INC

Products on ANDA 090678

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 090678

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 (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/090678Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/090678Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/01/2023	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/01/2023	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/01/2023	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/01/2023	SUPPL-13	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
02/07/2019	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/07/2019	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/07/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/07/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/03/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/03/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 090678

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/08/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/090678Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 090678

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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