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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076885
Company: MYLAN

Products on ANDA 076885

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076885

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076885Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76885TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/076885Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2023	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/31/2023	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/07/2019	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/07/2019	SUPPL-6	Labeling-Medication Guide, 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.
02/07/2019	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/03/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/03/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 076885

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/2013/076885Orig1s000lbl.pdf

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