Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077346
Company: SUN PHARM INDS INC

Products on ANDA 077346

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Discontinued	None	No	No
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Discontinued	None	No	No
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Discontinued	None	No	No
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077346

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/05/2007	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077346lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077346s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/01/2016	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
06/01/2016	SUPPL-29	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
05/10/2013	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
05/10/2013	SUPPL-11	Labeling-Patient Package Insert		Label is not available on this site.
01/31/2011	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/06/2015	SUPPL-5	Labeling		Label is not available on this site.
01/15/2009	SUPPL-4	Labeling		Label is not available on this site.

Labels for ANDA 077346

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/05/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077346lbl.pdf